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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 K931991
Device Name GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION
Applicant
Nomos Corp.
7800 Red Rd.
Suite 330-D
South Miami,  FL  33143
Applicant Contact MARVIN L SUSSMAN
Correspondent
Nomos Corp.
7800 Red Rd.
Suite 330-D
South Miami,  FL  33143
Correspondent Contact MARVIN L SUSSMAN
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/22/1993
Decision Date 08/20/1993
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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