The following data is part of a premarket notification filed by Unimed Hospital Supply Corp. with the FDA for Unimed Surgeon's Gowns.
Device ID | K871906 |
510k Number | K871906 |
Device Name: | UNIMED SURGEON'S GOWNS |
Classification | Gown, Surgical |
Applicant | UNIMED HOSPITAL SUPPLY CORP. POST OFFICE BOX 549 Prairie View, IL 60069 |
Contact | R Wiesbauer |
Correspondent | R Wiesbauer UNIMED HOSPITAL SUPPLY CORP. POST OFFICE BOX 549 Prairie View, IL 60069 |
Product Code | FYA |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-15 |
Decision Date | 1987-06-09 |