The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Proximate Disposable Skin Stapler.
| Device ID | K970079 |
| 510k Number | K970079 |
| Device Name: | PROXIMATE DISPOSABLE SKIN STAPLER |
| Classification | Stapler, Surgical |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Lorri Chavez |
| Correspondent | Lorri Chavez ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | GAG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-09 |
| Decision Date | 1997-03-11 |
| Summary: | summary |