510(k) K822990

CONVERTORS PRIMARY WOUND DRESSING II by American Hospital Supply Corp. — Product Code FRO

K822990 is an FDA 510(k) premarket notification submitted by American Hospital Supply Corp. for the device "CONVERTORS PRIMARY WOUND DRESSING II". The FDA issued a decision of Substantially Equivalent on April 12, 1983. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. American Hospital Supply Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1983
Date Received
October 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type