The following data is part of a premarket notification filed by Associated Medical Products Co. with the FDA for Skin Scrub Tray.
Device ID | K810558 |
510k Number | K810558 |
Device Name: | SKIN SCRUB TRAY |
Classification | Washer, Endometrial |
Applicant | ASSOCIATED MEDICAL PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HFD |
CFR Regulation Number | 884.1185 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-02 |
Decision Date | 1981-03-17 |