The following data is part of a premarket notification filed by All-hands Medical Supply, Inc. with the FDA for All-hands Medical Supply Suture Removal.
Device ID | K842953 |
510k Number | K842953 |
Device Name: | ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL |
Classification | Scissors, Orthopedic, Surgical |
Applicant | ALL-HANDS MEDICAL SUPPLY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HRR |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-27 |
Decision Date | 1984-08-21 |