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 Latchless Absorbable Hemostatic Clip*.
Device ID | K900122 |
510k Number | K900122 |
Device Name: | AUTO SUTURE LATCHLESS ABSORBABLE HEMOSTATIC CLIP* |
Classification | Clip, Implantable |
Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Curtis Raymond |
Correspondent | Curtis Raymond 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 | 1990-01-09 |
Decision Date | 1990-03-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884521133676 | K900122 | 000 |