The following data is part of a premarket notification filed by U. S. Surgical Corp. with the FDA for Auto Suture.
Device ID | K771589 |
510k Number | K771589 |
Device Name: | AUTO SUTURE |
Classification | Clamp, Surgical, General & Plastic Surgery |
Applicant | U. S. SURGICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GDJ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-08-19 |
Decision Date | 1977-12-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AUTO SUTURE 73078907 1065230 Live/Registered |
UNITED STATES SURGICAL CORPORATION 1976-03-02 |