FDA 510(k), K962649, SPORTROL RAPID STERILITY INDICATOR

FDA 510(k), K962649, SPORTROL RAPID STERILITY INDICATOR

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510(K) Number: K962649
Device Name: SPORTROL RAPID STERILITY INDICATOR
Manufacturer: MATTHEW SLIVA
Device Classification Name: Indicator, Chemical, Enzymatic, Sterilization Process
Regulation Number: MTC
Classification Product Code: KXA
Date Received: 07/08/1996
Decision Date: 09/26/1997
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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