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510(k) K864761

USI AUTOJECT INSULIN SYRINGE by Ulster Scientific, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1986
Date Received
December 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Ulster Scientific, Inc.

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  • K920562 — UNISTIK (March 27, 1992)
  • K902592 — EPC ELECTRONIC PIPETTING SYSTEM (July 19, 1990)
  • K895890 — AUTOPEN (February 16, 1990)
  • K894474 — THE AUTOLET LITE (August 18, 1989)
  • K885340 — AIR DISPLACEMENT PIPETTE (February 14, 1989)
  • K875354 — UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM (February 17, 1988)
  • K871571 — NEUROTIPS(TM) (June 18, 1987)
  • K871076 — WINPETTE (March 23, 1987)
  • K870078 — ACCUPEN(R) (March 17, 1987)

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