Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- ESIPolymer, Natural-Absorbable Gelatin Material3Product Code
- EWDProtector, Hearing (Insert)UProduct Code
- EWEProtector, Hearing (Circumaural)UProduct Code
- LEZAids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)UProduct Code
- LFAAids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)UProduct Code
- LFBButton, Nasal SeptalUProduct Code
- K131745BLOM-SINGER SEPTAL PERFORATION PROSTHESISUCleared 510(K)
- K013696SILMED NASAL SEPTAL BUTTONUCleared 510(K)
- K982667MICROMEDICS NASAL SEPTAL BUTTONUCleared 510(K)
- K972060NASAL SEPTAL BUTTONUCleared 510(K)
- K920994HOOD NASAL SEPTAL BUTTONUCleared 510(K)
- K901366INVOTEC SEPTAL BUTTONUCleared 510(K)
- K871072OMEGA NASAL SEPTAL BUTTONUCleared 510(K)
- K871200CUI NASAL SEPTUM BUTTONUCleared 510(K)
- K862497MICROTEK SEPTAL BUTTONUCleared 510(K)
- K850492NASAL SEPTAL BUTTONUCleared 510(K)
- Show All 12 Submissions
- LRAHearing Aid, TactileUProduct Code
- LXVApparatus, Vestibular AnalysisUProduct Code
- MCMImplant, Cochlear3Product Code
- MHEImplant, Auditory Brainstem3Product Code
- MJVDevice, Inflation, Middle EarUProduct Code
- MPVImplant, Hearing, Active, Middle Ear, Partially Implanted3Product Code
- MRKSystem, Imaging, Fluorescence3Product Code
- QNUTranscutaneous Electrical Nerve Stimulator For The Relief Of Congestion2Product Code
- OAAAid, Visual, For NauseaNProduct Code
- QLVField Generator Positioning Device1Product Code
- EPGStimulator, Transdermal3Product Code
- OAFImplant, Hearing, Active, Middle Ear, Totally Implanted3Product Code
- OAQElectronic Media, HyperacusisNProduct Code
- OWODrug-Eluting Sinus Stent3Product Code
- PGQCochlear Implant With Combined Electrical Stimulation And Acoustic Amplification3Product Code
- QJATympanostomy Tube Delivery Product With Drug3Product Code
- QOOVentilator Tubing And AccessoriesNProduct Code
- QOPRespiratory Humidifier For Emergency UseNProduct Code
- QOSContinuous VentilatorNProduct Code
- QOTEmergency VentilatorNProduct Code
- QOVCritical Care VentilatorNProduct Code
- QOXMulti-Patient Circuit ConnectorNProduct Code
- QQGOropharyngeal Electrical Stimulator2Product Code
- QVNCombined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus2Product Code
- QXGCooperative Powered Surgical Assist Device For Ent Surgery2Product Code
- QZCExternal Mechanical Stimulator For The Relief Of Congestion2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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- OphthalmicReview Panel
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- PathologyReview Panel
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- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
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- UnknownReview Panel
BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K131745
- 510(k) Type
- Traditional
- Applicant
- HELIX MEDICAL, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/17/2013
- Days to Decision
- 96 days
- Submission Type
- Summary