The following data is part of a premarket notification filed by Nmt Medical, Inc. with the FDA for Spetzler Round Handle Appliers, Models C-3753, C-3753t, C-3754, C-3754t.
| Device ID | K994191 |
| 510k Number | K994191 |
| Device Name: | SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T |
| Classification | Applier, Aneurysm Clip |
| Applicant | NMT MEDICAL, INC. 1733 CANTON LN. Marietta, GA 30062 |
| Contact | Ronald D Arkin |
| Correspondent | Ronald D Arkin NMT MEDICAL, INC. 1733 CANTON LN. Marietta, GA 30062 |
| Product Code | HCI |
| CFR Regulation Number | 882.4175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-13 |
| Decision Date | 2000-02-08 |
| Summary: | summary |