510(k) K954728

PROD NO. 01-1694 - 4X4 FOAM DRESSING by Continental Medical Laboratories, Inc. — Product Code KMF

K954728 is an FDA 510(k) premarket notification submitted by Continental Medical Laboratories, Inc. for the device "PROD NO. 01-1694 - 4X4 FOAM DRESSING". The FDA issued a decision of SN on September 23, 1996. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Continental Medical Laboratories, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
September 23, 1996
Date Received
October 13, 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