The following data is part of a premarket notification filed by Global Medical Prods, Inc. with the FDA for Global Medical Cutting Biopsy Needle.
| Device ID | K934256 |
| 510k Number | K934256 |
| Device Name: | GLOBAL MEDICAL CUTTING BIOPSY NEEDLE |
| Classification | Biopsy Needle |
| Applicant | GLOBAL MEDICAL PRODS, INC. WICKHAMS CAY 1 P.O. BOX 362 Road Town, Tortola, VG |
| Contact | Peter Clark |
| Correspondent | Peter Clark GLOBAL MEDICAL PRODS, INC. WICKHAMS CAY 1 P.O. BOX 362 Road Town, Tortola, VG |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-31 |
| Decision Date | 1994-03-28 |