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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Esophageal
510(k) Number K871244
Device Name HOOD ESOPHAGEAL PROSTHESIS
Applicant
Hood Laboratories
575 Washington St.
Pembroke,  MA  02359
Applicant Contact WILLIAM MCCALLUM,III
Correspondent
Hood Laboratories
575 Washington St.
Pembroke,  MA  02359
Correspondent Contact WILLIAM MCCALLUM,III
Regulation Number878.3610
Classification Product Code
ESW  
Date Received03/27/1987
Decision Date 04/13/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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