510(k) K984539

FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING by Ferris Mfg. Corp. — Product Code KMF

K984539 is an FDA 510(k) premarket notification submitted by Ferris Mfg. Corp. for the device "FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on March 1, 1999. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Ferris Mfg. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1999
Date Received
December 21, 1998
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