The following data is part of a premarket notification filed by Medical Insights, Inc. with the FDA for Biopsy/myelo/arthro/amniocent/basic Skin Prep Tray.
| Device ID | K924958 |
| 510k Number | K924958 |
| Device Name: | BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY |
| Classification | Kit, Surgical Instrument, Disposable |
| Applicant | MEDICAL INSIGHTS, INC. 193 WHITEHALL AVE. Mystic, CT 06355 |
| Contact | Carl G Barsanti |
| Correspondent | Carl G Barsanti MEDICAL INSIGHTS, INC. 193 WHITEHALL AVE. Mystic, CT 06355 |
| Product Code | KDD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-30 |
| Decision Date | 1993-06-07 |