The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Barrier Plus Surgeon Gowns.
Device ID | K801162 |
510k Number | K801162 |
Device Name: | BARRIER PLUS SURGEON GOWNS |
Classification | Gown, Isolation, Surgical |
Applicant | AMERICAN HOSPITAL SUPPLY CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FYC |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-05-15 |
Decision Date | 1980-05-23 |