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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 K895537
Device Name MODIFIED MEMORY RETRACTOR ARM
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 Received09/12/1989
Decision Date 09/22/1989
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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