Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring 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—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- NGUBalloon, Liver Tamponade2Product Code
- EYRTourniquet, Gastro-Urology1Product Code
- EXMTruss, Umbilical1Product Code
- EYNTray, Irrigation, Sterile2Product Code
- FBQTrocar, Gastro-Urology2Product Code
- FZGApparatus, Air Handling, Bench2Product Code
- FZHApparatus, Air Handling, Room2Product Code
- FZIApparatus, Air Handling, Enclosure2Product Code
- GAXTourniquet, Nonpneumatic1Product Code
- KCWEpilator, High Frequency, Needle-Type1Product Code
- KCXEpilator, High Frequency, Tweezer-Type1Product Code
- K973773DAPELLE HAIR REMOVER1Cleared 510(K)
- K973340TWEEZER-TYPE EPILATOR1Cleared 510(K)
- K973174SONIQUE HAIR REMOVER1Cleared 510(K)
- K973179FEMINIQUE SONIC HAIR REMOVER1Cleared 510(K)
- K972695FINALLY FREE1Cleared 510(K)
- K970338TWEEZER-TYPE EPILATOR1Cleared 510(K)
- K935706EPI 21Cleared 510(K)
- K943872COMMANDER MARK II HAIR REMOVAL SYSTEM1Cleared 510(K)
- K952117EPILATOR1Cleared 510(K)
- K915845HAIR TRONICS MODEL HT80001Cleared 510(K)
Show All 25 Submissions
- KCYTourniquet, Pneumatic1Product Code
- KPJChamber, Oxygen, Topical, Extremity2Product Code
- OJSTourniquet Kit1Product Code
- OLIFat Reducing Low Level Laser2Product Code
- PKTLaser For Disruption Of Adipocyte Cells For Aesthetic Use2Product Code
- QGXGeneral Use Pneumatic Tourniquet1Product Code
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
FINALLY FREE
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K972695
- 510(k) Type
- Traditional
- Applicant
- Mehl/Group Marketing
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/22/1997
- Days to Decision
- 96 days
- Submission Type
- Summary