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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 K925496
Device Name ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK
Applicant
Pymah Corp.
89 Rte. 206
P.O. Box 1114
Somerville,  NJ  08876
Applicant Contact RAYMOND P LARSSON
Correspondent
Pymah Corp.
89 Rte. 206
P.O. Box 1114
Somerville,  NJ  08876
Correspondent Contact RAYMOND P LARSSON
Regulation Number880.2800
Classification Product Code
FRC  
Date Received10/30/1992
Decision Date 02/01/1994
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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