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510(k) K874579

COEUR CONTROL SYRINGE by Coeur Laboratories, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1988
Date Received
November 6, 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 Coeur Laboratories, Inc.

  • K971712 — COEUR 130 ML ANGIOGRAPHIC SYRINGE (October 8, 1997)
  • K965214 — COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) (March 28, 1997)
  • K960965 — FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-02 (September 12, 1996)
  • K890292 — PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE (June 22, 1989)
  • K885138 — CAPILLARY TUBE, BLOOD COLLECTION (February 7, 1989)
  • K885202 — 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR (January 31, 1989)
  • K881646 — UROLOGICAL CATHETER (June 16, 1988)
  • K873597 — TUBING, POLYETHYLENE (November 12, 1987)
  • K823920 — COEURLOCK STERILE DISPOS. ANGIOGRAPHIC (February 18, 1983)

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