510(k) K821579

SKIN SCRUB-TRAY by Associated Medical Products Co. — Product Code LDR

K821579 is an FDA 510(k) premarket notification submitted by Associated Medical Products Co. for the device "SKIN SCRUB-TRAY". The FDA issued a decision of Substantially Equivalent on July 21, 1982. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), a Class II device regulated under 21 CFR 880.5725. Associated Medical Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1982
Date Received
May 28, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Infusion, Intravascular, Electronic
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type