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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 K841168
Device Name STERILIZATION PROCESS INDICATOR
Applicant
Parke-Davis Co.
2337 Parkdale Ave.
Brookville, Ontario,  CA K62 5WS
Correspondent
Parke-Davis Co.
2337 Parkdale Ave.
Brookville, Ontario,  CA K62 5WS
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received03/19/1984
Decision Date 05/09/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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