The following data is part of a premarket notification filed by Cunningham Woodland, Inc. with the FDA for Suture Removal Set(displsable).
Device ID | K811086 |
510k Number | K811086 |
Device Name: | SUTURE REMOVAL SET(DISPLSABLE) |
Classification | Kit, Surgical Instrument, Disposable |
Applicant | CUNNINGHAM WOODLAND, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KDD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-21 |
Decision Date | 1981-05-01 |