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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K980820
Device Name PHILIPS EASYGUIDE
Applicant
Philips Medical Systems, Inc.
710 Bridgeport Ave.
P.O. Box 860
Shelton,  CT  06484
Applicant Contact FRANK GIANELLI
Correspondent
Philips Medical Systems, Inc.
710 Bridgeport Ave.
P.O. Box 860
Shelton,  CT  06484
Correspondent Contact FRANK GIANELLI
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/03/1998
Decision Date 10/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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