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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 K872877
Device Name TARGET PROGRAM & EPSON HX-20 COMPUTER
Applicant
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218
Applicant Contact DEBRA A POWERS
Correspondent
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218
Correspondent Contact DEBRA A POWERS
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/21/1987
Decision Date 02/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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