The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Proximate Linear Cutter Thick Tissue Inst..
| Device ID | K892927 |
| 510k Number | K892927 |
| Device Name: | PROXIMATE LINEAR CUTTER THICK TISSUE INST. |
| Classification | Stapler, Surgical |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | James O'donnell |
| Correspondent | James O'donnell ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | GAG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-21 |
| Decision Date | 1989-05-26 |