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510(k) K122787

COMFORT EZ by Simple Diagnostics, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2012
Date Received
September 11, 2012
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 Simple Diagnostics, Inc.

  • K120921 — CLEVER CHOICE (August 21, 2012)
  • K121632 — COMFORT EZ (August 10, 2012)

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