510(k) K830881

AMPERCIDE DISINFECTANT ACCESSORY TO - by American Medical Products, Inc. — Product Code FKX

K830881 is an FDA 510(k) premarket notification submitted by American Medical Products, Inc. for the device "AMPERCIDE DISINFECTANT ACCESSORY TO -". The FDA issued a decision of Substantially Equivalent on Jun 2, 1983. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. American Medical Products, Inc. has 29 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 2, 1983
Date Received
Mar 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type
510(k)

Source: FDA 510(k) database entry for K830881. Report a data issue: hello@regdatalab.com.