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510(k) K942937

SHARPSAFE CAT NO. 4105, 4115 AND 4120 by Smiths Industries Medical Systems, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1994
Date Received
June 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
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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