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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 K874833
Device Name ARC ADAPTER ASSEMBLY
Applicant
Medical Equipment Development Co., Inc.
1001 Orchard Dr.
Cinnaminson,  NJ  08077
Applicant Contact ROBERT PALMER
Correspondent
Medical Equipment Development Co., Inc.
1001 Orchard Dr.
Cinnaminson,  NJ  08077
Correspondent Contact ROBERT PALMER
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/24/1987
Decision Date 03/03/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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