510(k) K871616

CUSTOM PROCEDURE TRAYS by Medical Custom Products, Inc. — Product Code FMF

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
December 11, 1987
Date Received
April 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type