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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name holder, head, neurosurgical (skull clamp)
510(k) Number K893911
Device Name MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM
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 Number882.4460
Classification Product Code
HBL  
Date Received05/30/1989
Decision Date 08/29/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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