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510(k) K811203

SAF SINGLE-USE AEROSOL FILTER by Sorensen Research — Product Code GCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1981
Date Received
May 1, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class
Class I
Regulation Number
878.4680
Review Panel
SU
Submission Type

Other clearances by Sorensen Research

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  • K833094 — TRANSDUCER DOME SD104 (November 3, 1983)
  • K833095 — TRANSDUCER DOME SD105 (November 3, 1983)
  • K832957 — FLOW-DIRECTED HEPARIN COATED THERMODIL (September 29, 1983)
  • K831506 — DISP. TRANSDUCER W/MONITORING KIT TRANS (August 12, 1983)
  • K831939 — TALL FLOOR STAND TFS-01 (July 19, 1983)
  • K831505 — THORACIC GAUGE #TG-60 -VACUUM REGULATOR (July 12, 1983)
  • K820706 — WATERLESS SEAL & VACUUM REGULATOR (April 9, 1982)

Other clearances for product code GCY

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  • K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 (December 12, 1996)
  • K960099 — PENROSE DRAIN MODELS 6001 - 6007 (March 11, 1996)
  • K950754 — MACRO SUCTION TUBE MODEL NO 10061 (April 25, 1995)
  • K936223 — PRESSURE IRRIGATING SYSTEM (May 12, 1994)
  • K930615 — AUTOVAC CLOSED WOUND SUCTION SYSTEM (February 22, 1994)
  • K933319 — BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTE (October 27, 1993)
  • K933305 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE (October 5, 1993)
  • K933306 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (October 5, 1993)