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510(k) K870078

ACCUPEN(R) by Ulster Scientific, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1987
Date Received
January 8, 1987
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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  • 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)
  • K864761 — USI AUTOJECT INSULIN SYRINGE (December 16, 1986)

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