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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K983088
Device Name INSTACINE D-2000
Applicant
Fidelity Medical, Inc.
10 Madison Rd., Unit C
Fairfield,  NJ  07004
Applicant Contact SPENCER J ANGEL
Correspondent
Fidelity Medical, Inc.
10 Madison Rd., Unit C
Fairfield,  NJ  07004
Correspondent Contact SPENCER J ANGEL
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/28/1998
Decision Date 09/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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