510(k) K964231

NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) by North American Sterilization & Packaging Co. — Product Code KMF

K964231 is an FDA 510(k) premarket notification submitted by North American Sterilization & Packaging Co. for the device "NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)". The FDA issued a decision of Substantially Equivalent on March 10, 1997. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. North American Sterilization & Packaging Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1997
Date Received
October 23, 1996
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