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510(k) K883114

SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1 by Pmt Corp. — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1988
Date Received
July 25, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

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  • K935560 — PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS) (November 7, 1994)
  • K933079 — ELECTROCAUTERY SYSTEM MODEL 1980 (February 22, 1994)

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