510(k) K002129

FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN by Ferris Mfg. Corp. — Product Code MGQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2000
Date Received
July 14, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type