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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K924596
Device Name SES-2012 AUTOMATIC STEAM STERILIZER
Applicant
Porter Instrument Co., Inc.
245 Township Line Rd.
P.O. Box 907
Hatfield,  PA  19440
Applicant Contact STEPHEN D LOEFFLER
Correspondent
Porter Instrument Co., Inc.
245 Township Line Rd.
P.O. Box 907
Hatfield,  PA  19440
Correspondent Contact STEPHEN D LOEFFLER
Regulation Number880.6880
Classification Product Code
FLE  
Date Received09/11/1992
Decision Date 04/15/1994
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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