510(k) K851719

1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS by Artiberia — Product Code EZZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1985
Date Received
April 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Vas Deferens
Device Class
Class III
Regulation Number
Review Panel
GU
Submission Type