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510(k) K962649

SPORTROL RAPID STERILITY INDICATOR by North American Science Assoc., Inc. — Product Code MTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1997
Date Received
July 8, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Chemical, Enzymatic, Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

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  • K983451 — CHALLENGE TEST PACK (April 23, 1999)

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