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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K942558
Device Name INSTACINE
Applicant
Fidelity Medical, Inc.
6 Vreeland Rd.
Florham Park,  NJ  07932
Applicant Contact RONEN GANS
Correspondent
Fidelity Medical, Inc.
6 Vreeland Rd.
Florham Park,  NJ  07932
Correspondent Contact RONEN GANS
Regulation Number892.2010
Classification Product Code
LMB  
Date Received05/31/1994
Decision Date 05/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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