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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 K952995
Device Name ATI ETHYLENE OXIDE STERILIZATION INDICATOR
Applicant
Pymah Corp.
500 Rte. 202 N.
Flemington,  NJ  08822
Applicant Contact GEORGE LEVENDUSKY
Correspondent
Pymah Corp.
500 Rte. 202 N.
Flemington,  NJ  08822
Correspondent Contact GEORGE LEVENDUSKY
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received06/28/1995
Decision Date 02/22/1996
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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