Anesthesiology
Review Panel
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- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
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- Obstetrical and GynecologicalReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- EAJApron, Leaded1Product Code
- EAKScreen, Leaded, Operator Radiation Protector1Product Code
- IWOApron, Protective1Product Code
- IWPRadiographic Protective Glove1Product Code
- IWQCurtain, Protective, Radiographic1Product Code
- IWRHolder, Syringe, Lead1Product Code
- IWSShield, Eye, Radiological1Product Code
- IWTShield, Gonadal1Product Code
- IWWShield, Vial1Product Code
- IWXBarrier, Control Panel, X-Ray, Movable1Product Code
- KPYShield, Protective, Personnel1Product Code
- K110900DISPOSABLE THYROID COLLAR1Cleared 510(K)
- K962622INTRA-ORAL THERMOPLASTIC SHIELD1Cleared 510(K)
- K954456THERMOPLASTIC SHIELD1Cleared 510(K)
- K954146UTK-DTE AUTILARY SHIELD1Cleared 510(K)
- K953610AUKULYTE1Cleared 510(K)
- K9510042001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)1Cleared 510(K)
- K951003KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)1Cleared 510(K)
- K940539STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM1Cleared 510(K)
- K934206MAVIG ANGIO SHIELD MODELS 6290 & 62721Cleared 510(K)
- K912378DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS1Cleared 510(K)
Show All 25 Submissions
- PDKCream For X-Ray Attenuation2Product Code
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K951003
- 510(k) Type
- Traditional
- Applicant
- KENEX LTD.
- Country
- United Kingdom
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/3/1995
- Days to Decision
- 47 days
- Submission Type
- Summary