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510(k) K810627

MODEL 1301 BIOTAC (TM) by Progress Mankind Technology — Product Code GEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1981
Date Received
March 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
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)
  • 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)

Other clearances for product code GEA

  • K003965 — MRI SAFE INSTRUMENTS (March 16, 2001)
  • K982472 — GENICON TROCAR (February 4, 1999)
  • K954599 — CONMED TROGARD ELECTRONIC TROCAR SYSTEM (November 27, 1995)
  • K922460 — ORIGIN SECONDARY CANNULA AND TROCAR (September 16, 1992)
  • K920110 — ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE (April 2, 1992)
  • K911262 — DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER (June 20, 1991)
  • K904881 — DISPOSABLE YANKAUER SUCTION TUBE (March 6, 1991)
  • K903416 — CANNULA, SURGICAL (November 23, 1990)
  • K904218 — SUCTION SYSTEM (October 31, 1990)
  • K901717 — KLEIN MICRO-CANNULA(TM) (May 24, 1990)