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510(k) K050971

BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) by Biovalve Technologies, Inc. — Product Code LZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2005
Date Received
April 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Biovalve Technologies, Inc.

  • K051985 — BIOVALVE MINI-JECT NEEDLEFREE INJECTOR (August 17, 2005)
  • K032976 — BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 (April 16, 2004)

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