510(k) K811965

VISITEC NEEDLE RANGE (GASTERUROLOGY) by Visitec Co. — Product Code FHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1981
Date Received
July 10, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Gastro-Urology
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type