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510(k) K801127

MACROVAC by Progress Mankind Technology — Product Code JOL

K801127 is an FDA 510(k) premarket notification submitted by Progress Mankind Technology for the device "MACROVAC". The FDA issued a decision of Substantially Equivalent on May 30, 1980. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Progress Mankind Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1980
Date Received
May 12, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter And Tip, Suction
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
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 JOL

  • K051370 — STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F (August 12, 2005)
  • K000265 — PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (July 12, 2001)
  • K000266 — PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (July 12, 2001)
  • K003402 — WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FO (May 1, 2001)
  • K994321 — STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (October 25, 2000)
  • K974758 — HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (March 9, 1998)
  • K974759 — HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (March 9, 1998)
  • K974397 — STERILE SALINE FOR CATHETER CARE (February 10, 1998)
  • K973734 — STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (February 5, 1998)
  • K972372 — GERM TRAPPER SUCTION TUBE HOLDER (December 11, 1997)

FDA data resources