The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Auto Suture Titanium Hemostatic Clip.
Device ID | K853650 |
510k Number | K853650 |
Device Name: | AUTO SUTURE TITANIUM HEMOSTATIC CLIP |
Classification | Clip, Implantable |
Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Walter Henning |
Correspondent | Walter Henning UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-03 |
Decision Date | 1985-09-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10889942313938 | K853650 | 000 |