510(k) K854726

MEDI-WIPES UNITED ANTISEPTIC SKIN PREP by Pfizer, Inc. — Product Code EXB

K854726 is an FDA 510(k) premarket notification submitted by Pfizer, Inc. for the device "MEDI-WIPES UNITED ANTISEPTIC SKIN PREP". The FDA issued a decision of Substantially Equivalent on February 24, 1986. The device falls under product code EXB (Collector, Ostomy), a Class I device regulated under 21 CFR 876.5900. Pfizer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1986
Date Received
November 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Ostomy
Device Class
Class I
Regulation Number
876.5900
Review Panel
GU
Submission Type