The following data is part of a premarket notification filed by Surgicot, Inc. with the FDA for Suogipeel Packaging System.
Device ID | K771846 |
510k Number | K771846 |
Device Name: | SUOGIPEEL PACKAGING SYSTEM |
Classification | Wrap, Sterilization |
Applicant | SURGICOT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-09-28 |
Decision Date | 1977-10-13 |