The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for U.v.a.c. Handler Set.
Device ID | K822382 |
510k Number | K822382 |
Device Name: | U.V.A.C. HANDLER SET |
Classification | Curette, Suction, Endometrial (and Accessories) |
Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HHK |
CFR Regulation Number | 884.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-09 |
Decision Date | 1982-08-25 |