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510(k) K845036

TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600 by Progress Mankind Technology — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1985
Date Received
December 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tissue Expander And Accessories
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Progress Mankind Technology

  • K883314 — PMT 3721-1 EPIDURAL KIT (October 28, 1988)
  • K881616 — PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1 (September 9, 1988)
  • K871663 — PMT TRACTION TONGS (June 19, 1987)
  • K854157 — PMT ACCUPRESSURE INFUSION SYSTEM 3601 (February 13, 1986)
  • K845035 — ELECTRODE FOR NEUROLOGICAL SURGERY 2111 (July 30, 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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