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510(k) K812325

INTK-08 8 FRENCH INTRODUCER KIT W/SIDE by Sorensen Research — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1981
Date Received
August 17, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
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)

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