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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator/Data Processing Module, For Clinical Use
510(k) Number K854265
Device Name SIMULATOR
Applicant
Cygnus of South Florida, Inc.
Emerald Hills Professional Pk
4700p Sheridan St.
Hollywood,  FL  33021
Applicant Contact DAVID FRIEDMAN
Correspondent
Cygnus of South Florida, Inc.
Emerald Hills Professional Pk
4700p Sheridan St.
Hollywood,  FL  33021
Correspondent Contact DAVID FRIEDMAN
Regulation Number862.2100
Classification Product Code
JQP  
Date Received10/23/1985
Decision Date 03/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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