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510(k) K952516

PRO-VENT, LINE DRAW, PULSATOR by Smiths Industries Medical Systems, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1995
Date Received
May 31, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Smiths Industries Medical Systems, Inc.

  • K972385 — FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED (January 20, 1998)
  • K965017 — REGIONAL ANESTHESIA TRAYS (March 14, 1997)
  • K962175 — PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE (January 17, 1997)
  • K962931 — SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT (October 21, 1996)
  • K963570 — SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) (October 18, 1996)
  • K960429 — PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. IN (May 2, 1996)
  • K953485 — SIMS CPAP SYSTEM (October 26, 1995)
  • K953483 — SIMS BLUE LINE ENDOBRONCHIAL TUBE (October 24, 1995)
  • K932947 — WALLACE Y-CAN (September 1, 1995)
  • K932946 — WALLACE IV CANNULA (September 1, 1995)

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