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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K855120
Device Name ATI DISPOSABLE BIOLOGICAL TEST PACK
Applicant
Parke-Davis Co.
870 Parkdale Rd.
Rochester,  MI  48307
Applicant Contact CLEARY
Correspondent
Parke-Davis Co.
870 Parkdale Rd.
Rochester,  MI  48307
Correspondent Contact CLEARY
Regulation Number880.2800
Classification Product Code
FRC  
Date Received12/23/1985
Decision Date 06/18/1986
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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