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510(k) K830605

PUMP PALL AMBULATORY INSULIN INFUSION by Biomedical Devices, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1983
Date Received
February 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Biomedical Devices, Inc.

  • K955439 — THE REEL THING (MODIFICATION) (December 26, 1995)
  • K931847 — BIO-PREP CEMENT RESTRICTOR (June 28, 1994)
  • K931846 — BIO-PREP (January 21, 1994)
  • K925982 — BMD AIR/OXYGEN BLENDER (October 7, 1993)
  • K903533 — STERI-SHIELD (October 19, 1990)
  • K902677 — STERI-SHIELD (August 17, 1990)

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