The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Ethicon Endosuture System.
| Device ID | K963329 |
| 510k Number | K963329 |
| Device Name: | ETHICON ENDOSUTURE SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | John D Paulson, Ph.d. |
| Correspondent | John D Paulson, Ph.d. ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | GCJ |
| Subsequent Product Code | GAM |
| Subsequent Product Code | GAW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-23 |
| Decision Date | 1996-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031148168 | K963329 | 000 |