Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- MiscellaneousMiscellaneous
- 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
- OGPCricothyrotomy Kit2Product Code
- OGVTracheostomy Cleaning Tray2Product Code
- OGWTracheostomy Kit2Product Code
- MYBPillow, Cervical (For Mild Sleep Apnea)2Product Code
- EPNPump, Nebulizer, Manual1Product Code
- EPPSplint, Nasal1Product Code
- ETFUnit, Examining/Treatment, Ent1Product Code
- K953457JEDMED SPECTRUM ENT CABINET1Cleared 510(K)
- K945395PREMIER MIRROR WARMER1Cleared 510(K)
- K932470LANGGASSE 901Cleared 510(K)
- K911901MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE1Cleared 510(K)
- K910781#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES1Cleared 510(K)
- K910243MOBILE TREATMENT CART1Cleared 510(K)
- K896273SYSTEMA ENT CABINET1Cleared 510(K)
- K896298JEDMED S CHAIR1Cleared 510(K)
- K881958JEDMED MAXIM ENT CABINET1Cleared 510(K)
- K860940MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT1Cleared 510(K)
Show All 32 Submissions
- EWTDevice, Antichoke, Suction3Product Code
- EWWDevice, Antichoke, Tongs3Product Code
- JPWPump, Nebulizer, Electrically Powered1Product Code
- KCJApplicator, Ent1Product Code
- KCLBlower, Powder, Ent1Product Code
- KCMDropper, Ent1Product Code
- KCNEar Wick1Product Code
- KCONasal Spray, Ent Delivery1Product Code
- KCPSyringe, Ent1Product Code
- KMAIrrigator, Powered Nasal1Product Code
- KTHDevice, Anti-Stammering1Product Code
- LRDApplicator, Ent Drug1Product Code
- PKAExternal Upper Esophageal Sphincter (Ues) Compression Device2Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PREMIER MIRROR WARMER
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K945395
- 510(k) Type
- Traditional
- Applicant
- PREMIER DENTAL PRODUCTS CO.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/18/1995
- Days to Decision
- 76 days
- Submission Type
- Summary