Home / 510(k) Clearances / K803206

510(k) K803206

SUCTION PROBE by Bemis Health Care — Product Code JOL

K803206 is an FDA 510(k) premarket notification submitted by Bemis Health Care for the device "SUCTION PROBE". The FDA issued a decision of Substantially Equivalent on January 21, 1981. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Bemis Health Care has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1981
Date Received
December 17, 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 Bemis Health Care

  • K885019 — BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI. (January 25, 1989)
  • K822556 — CRITICAL MEASUREMENT UNIT (October 18, 1982)
  • K822557 — SPECIMEN ADAPTOR (October 18, 1982)
  • K771737 — SUCTION CANISTER (December 20, 1977)
  • K771738 — MALE URINAL (September 28, 1977)
  • K771733 — 8 EMESIS BASIN (September 28, 1977)
  • K760393 — BED PAN, STACKABLE (AUTOCLAVABLE) (August 23, 1976)
  • K760072 — CARAFE, PERSONAL, 1-QT SEMI-RECTANGULAR (July 20, 1976)
  • K760073 — BASIN, WASH, 6-QT RECTANGULAR (July 20, 1976)
  • K760071 — TRAY, PERSONAL, RECTANG. 8 1/2 X 5 1/4 (July 20, 1976)

Other clearances for product code JOL

  • K051370 — STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F (August 12, 2005)
  • K000266 — PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (July 12, 2001)
  • K000265 — PRIMARY CARE SOLUTIONS STERILE WATER 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