510(k) K851516

CHERMEL SCALP VEIN SET by Cher Mel Corp. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1985
Date Received
April 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type