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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 K901670
Device Name GNOMOS STEREOTACTIC DEVICE
Applicant
Medical Equipment Development Co., Inc.
1001 Orchard Dr.
Cinnaminson,  NJ  08077
Applicant Contact ROBERTA PALMER
Correspondent
Medical Equipment Development Co., Inc.
1001 Orchard Dr.
Cinnaminson,  NJ  08077
Correspondent Contact ROBERTA PALMER
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/10/1990
Decision Date 07/03/1990
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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