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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 K895638
Device Name STEAM STERILIZER (AUTOCLAVE), DENTAL
Applicant
Porter Instrument Co., Inc.
245 Township Line Rd.
P.O. Box 907
Hatfield,  PA  19440
Applicant Contact LUICH, P.E.
Correspondent
Porter Instrument Co., Inc.
245 Township Line Rd.
P.O. Box 907
Hatfield,  PA  19440
Correspondent Contact LUICH, P.E.
Regulation Number880.6880
Classification Product Code
FLE  
Date Received09/19/1989
Decision Date 02/22/1990
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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