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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 K934874
Device Name STERIGAGE EO 100%
Applicant
Pymah Corp.
89 Rte. 206
P.O. Box 1114
Somerville,  NJ  08876
Applicant Contact BERNARD KONOPKO, R.PH., P.D.
Correspondent
Pymah Corp.
89 Rte. 206
P.O. Box 1114
Somerville,  NJ  08876
Correspondent Contact BERNARD KONOPKO, R.PH., P.D.
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received10/12/1993
Decision Date 04/18/1995
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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