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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 K955397
Device Name MAYFIELD-ACCISS WORKSTATION
Applicant
Nomos Corp.
2591 Wexford Bayne Rd.
Suite 400
Sewickley,  PA  15143
Applicant Contact MARVIN L SUSSMAN
Correspondent
Nomos Corp.
2591 Wexford Bayne Rd.
Suite 400
Sewickley,  PA  15143
Correspondent Contact MARVIN L SUSSMAN
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/24/1995
Decision Date 04/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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