510(k) K811446

HYDRON WOUND DRESSING KIT by National Patent Development Corp. — Product Code KMF

K811446 is an FDA 510(k) premarket notification submitted by National Patent Development Corp. for the device "HYDRON WOUND DRESSING KIT". The FDA issued a decision of Substantially Equivalent on June 12, 1981. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. National Patent Development Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1981
Date Received
May 22, 1981
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