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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 K936019
Device Name NOMOS STEREOTACTIC BIOPSY INSTRUMENTS
Applicant
Nomos Corp.
2593 Wexford Bayne Rd.
Suite 315
Sewickley,  PA  15143
Applicant Contact MARVIN L SUSSMAN
Correspondent
Nomos Corp.
2593 Wexford Bayne Rd.
Suite 315
Sewickley,  PA  15143
Correspondent Contact MARVIN L SUSSMAN
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/17/1993
Decision Date 03/22/1994
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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