510(k) K873771

HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO by American V. Mueller — Product Code GYK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1987
Date Received
September 16, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Shunt System Implantation
Device Class
Class I
Regulation Number
882.4545
Review Panel
NE
Submission Type