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
- K944882IRRIGATION TRAY2Cleared 510(K)
- K923941IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE2Cleared 510(K)
- K923938IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER2Cleared 510(K)
- K923939IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER2Cleared 510(K)
- K923940IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE2Cleared 510(K)
- K900148KIT PAK IRRIGATION TRAY2Cleared 510(K)
- K900737PISTON IRRIGATION TRAY2Cleared 510(K)
- K900736BULB IRRIGATION TRAY2Cleared 510(K)
- K801783CATHETER IRRIGATION TRAYS, #3300, 3310 &2Cleared 510(K)
- K792082GAVAGE FEEDING SET2Cleared 510(K)
Show All 15 Submissions
- 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
- 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
CATHETER IRRIGATION TRAYS, #3300, 3310 &
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K801783
- 510(k) Type
- Traditional
- Applicant
- THE HEALTHCARE GROUP LABORATORIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/13/1980
- Days to Decision
- 16 days