The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Sundt Slim-line Aneurysm Clip Applier.
| Device ID | K982379 |
| 510k Number | K982379 |
| Device Name: | SUNDT SLIM-LINE ANEURYSM CLIP APPLIER |
| Classification | Applier, Aneurysm Clip |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Janet G Johnson |
| Correspondent | Janet G Johnson JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | HCI |
| CFR Regulation Number | 882.4175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-08 |
| Decision Date | 1998-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704002734 | K982379 | 000 |
| 10886704002727 | K982379 | 000 |
| 10886704002710 | K982379 | 000 |