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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor, Self-Retaining, For Neurosurgery
510(k) Number K874829
Device Name MEDCO MEMORY RETRACTOR SYSTEM
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 Number882.4800
Classification Product Code
GZT  
Date Received11/24/1987
Decision Date 03/24/1988
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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