510(k) K951327

COMFEEL PLUS CONTOUR DRESSING by Richard Hamer Assoc., Inc. — Product Code KMF

K951327 is an FDA 510(k) premarket notification submitted by Richard Hamer Assoc., Inc. for the device "COMFEEL PLUS CONTOUR DRESSING". The FDA issued a decision of Substantially Equivalent on April 28, 1995. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Richard Hamer Assoc., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1995
Date Received
March 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type