The following data is part of a premarket notification filed by Medcare Products with the FDA for Disposable Suture Removal Scissors.
Device ID | K812555 |
510k Number | K812555 |
Device Name: | DISPOSABLE SUTURE REMOVAL SCISSORS |
Classification | Scissors, Medical, Disposable |
Applicant | MEDCARE PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JOK |
CFR Regulation Number | 880.6820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-09-08 |
Decision Date | 1981-11-16 |