The following data is part of a premarket notification filed by Surgeons Choice, Inc. with the FDA for Disposable Skin Stapler.
Device ID | K830768 |
510k Number | K830768 |
Device Name: | DISPOSABLE SKIN STAPLER |
Classification | Clip, Removable (skin) |
Applicant | SURGEONS CHOICE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FZQ |
CFR Regulation Number | 878.4320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-11 |
Decision Date | 1983-04-12 |