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510(k) K813324

BODAI SWIVEL Y by Sontek Industries, Inc. — Product Code BSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1981
Date Received
November 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheters, Suction, Tracheobronchial
Device Class
Class I
Regulation Number
868.6810
Review Panel
AN
Submission Type

Other clearances by Sontek Industries, Inc.

  • K833373 — BODIA BRONCH-SAF DOUBLE SWIVEL (November 3, 1983)
  • K833372 — BODIA TRACH-SAF DOUBLE SWIVEL (November 3, 1983)
  • K833361 — TUBE-TITLE (November 3, 1983)
  • K833374 — BITE-BLOCK (November 3, 1983)
  • K812720 — BODAI PATIENT COMMUNICATOR (November 5, 1981)
  • K811241 — BODAI SUCTION -SAFE 4 (May 27, 1981)

Other clearances for product code BSY

  • K031997 — MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM (November 25, 2003)
  • K992902 — AMBU HAND POWER SUCTION PUMP (October 25, 1999)
  • K982945 — DUAL PURPOSE CLOSED CATHETER (September 22, 1998)
  • K981910 — SUCTION CATHETER (August 24, 1998)
  • K972258 — HI-CARE CLOSED SUCTION SYSTEM (December 29, 1997)
  • K973199 — AMSINO SUCTION CATHETER (September 10, 1997)
  • K961707 — TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM (March 11, 1997)
  • K964369 — TRACH CARE SET WITH MICROBAN (February 11, 1997)
  • K960488 — NEO 2 LINE SUCTION SYSTEM (April 26, 1996)
  • K955831 — ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (March 28, 1996)