The following data is part of a premarket notification filed by Global Medical Products, Ltd. with the FDA for Global Medical Products Potts Cournand, Seldinger Style Needle, Single, Winged Single Wall Introducer Needle.
| Device ID | K951448 |
| 510k Number | K951448 |
| Device Name: | GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE |
| Classification | Trocar |
| Applicant | GLOBAL MEDICAL PRODUCTS, LTD. OMAR HODGE BUILDING WICKHAMS CAY 1, P.O. BOX 362 Road Town, Tortola, VG |
| Contact | Peter Clark |
| Correspondent | Peter Clark GLOBAL MEDICAL PRODUCTS, LTD. OMAR HODGE BUILDING WICKHAMS CAY 1, P.O. BOX 362 Road Town, Tortola, VG |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-29 |
| Decision Date | 1996-03-27 |