The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Barrier Surgical Gown.
Device ID | K852870 |
510k Number | K852870 |
Device Name: | BARRIER SURGICAL GOWN |
Classification | Gown, Surgical |
Applicant | SURGIKOS, INC. P.O. BOX 130 Arlington, TX 76010 |
Contact | Christal O Fisher |
Correspondent | Christal O Fisher SURGIKOS, INC. P.O. BOX 130 Arlington, TX 76010 |
Product Code | FYA |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-08 |
Decision Date | 1985-07-23 |