The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Drapes, Barrier, Sterile Patient Ready.
Device ID | K760212 |
510k Number | K760212 |
Device Name: | DRAPES, BARRIER, STERILE PATIENT READY |
Classification | Drape, Surgical |
Applicant | SURGIKOS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-12 |
Decision Date | 1976-08-11 |