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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 K952408
Device Name ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION
Applicant
Pymah Corp.
8904 Paddock Ln.
Potomac,  MD  20854
Applicant Contact BERNARD KONOPKO
Correspondent
Pymah Corp.
8904 Paddock Ln.
Potomac,  MD  20854
Correspondent Contact BERNARD KONOPKO
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received05/22/1995
Decision Date 07/06/1995
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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