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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name retractor
510(k) Number K921019
Device Name HARGIS RECTAL SELF RETRATION SYSTEM
Applicant
MEDIN CORP.
111 LESTER ST.
WALLINGTON,  NJ  07057
Applicant Contact SCHAINHOLZ
Correspondent
MEDIN CORP.
111 LESTER ST.
WALLINGTON,  NJ  07057
Correspondent Contact SCHAINHOLZ
Regulation Number878.4800
Classification Product Code
GAD  
Date Received03/03/1992
Decision Date 07/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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