The following data is part of a premarket notification filed by Associated Medical Products Co. with the FDA for Skin Scrub-tray.
Device ID | K821579 |
510k Number | K821579 |
Device Name: | SKIN SCRUB-TRAY |
Classification | Controller, Infusion, Intravascular, Electronic |
Applicant | ASSOCIATED MEDICAL PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LDR |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-05-28 |
Decision Date | 1982-07-21 |