The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Lapra-ty* Suture Clip.
| Device ID | K931492 |
| 510k Number | K931492 |
| Device Name: | LAPRA-TY* SUTURE CLIP |
| Classification | Clip, Implantable |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | John Paulson |
| Correspondent | John Paulson ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-25 |
| Decision Date | 1993-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031206882 | K931492 | 000 |