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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Tracheal, Preformed/Molded
510(k) Number K873742
Device Name HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES
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 Number878.3720
Classification Product Code
NWA  
Date Received09/16/1987
Decision Date 10/01/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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