The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Ethicon* Surgical Sutures W/compress Bol.
Device ID | K812819 |
510k Number | K812819 |
Device Name: | ETHICON* SURGICAL SUTURES W/COMPRESS BOL |
Classification | Retention Device, Suture |
Applicant | ETHICON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KGS |
CFR Regulation Number | 878.4930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-07 |
Decision Date | 1981-11-20 |