510(k) K970133

AMERIGEL OINTMENT by Amerx Health Care Corp. — Product Code MGQ

Clearance Details

Decision
SN ()
Decision Date
April 14, 1997
Date Received
January 15, 1997
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