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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 K874644
Device Name STEAM AUTOCLAVE CONTROL. & DATALOG. BY DATACON
Applicant
Pharmetics, Inc.
62 Enter Ln.
Hauppauge,  NY  11788
Applicant Contact THEODORE M SHLISKY
Correspondent
Pharmetics, Inc.
62 Enter Ln.
Hauppauge,  NY  11788
Correspondent Contact THEODORE M SHLISKY
Regulation Number880.6880
Classification Product Code
FLE  
Date Received11/13/1987
Decision Date 01/27/1988
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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