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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: 07/08/1996
Date Received: 09/26/1997
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: SPORTROL RAPID STERILITY INDICATOR
Manufacturer: MATTHEW SLIVA
Device Classification Name: Indicator, Chemical, Enzymatic, Sterilization Process
Regulation Number: MTC
Classification Product Code: 07/08/1996
Date Received: 09/26/1997
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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