510(k) K761229

ANAL/RECTAL SYRINGE by Ace Orthopedic Manufacturing Co. — Product Code KOA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1977
Date Received
December 10, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Instruments, G-U, Manual (And Accessories)
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type