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510(k) K881616

PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1 by Progress Mankind Technology — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1988
Date Received
April 12, 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

Other clearances by Progress Mankind Technology

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  • K845035 — ELECTRODE FOR NEUROLOGICAL SURGERY 2111 (July 30, 1985)
  • K845036 — TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600 (June 26, 1985)
  • K834047 — PMT-HALO/ORTHOPEDIC JACKET SYSTEM (February 17, 1984)
  • K831329 — PMT VAXIOM STEREOTACTIC SYS #FX001 (June 15, 1983)
  • K830530 — TEMP TRACE (April 6, 1983)
  • K812744 — LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER (December 3, 1981)
  • K810627 — MODEL 1301 BIOTAC (TM) (April 2, 1981)

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