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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K983451
Device Name CHALLENGE TEST PACK
Applicant
North American Science Assoc., Inc.
2261 Tracy Rd.
Northwood,  OH  43619
Applicant Contact MATTHEW SLIVA
Correspondent
North American Science Assoc., Inc.
2261 Tracy Rd.
Northwood,  OH  43619
Correspondent Contact MATTHEW SLIVA
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received09/30/1998
Decision Date 04/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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