510(k) K842324

PERFOURM by Cutter Laboratories, Inc. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1984
Date Received
June 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type