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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Disposable
510(k) Number K901438
Device Name SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE
Applicant
Telemed Systems, Inc.
8 Kane Industrial Dr.
Hudson,  MA  01749
Applicant Contact JOHN A CHAVES
Correspondent
Telemed Systems, Inc.
8 Kane Industrial Dr.
Hudson,  MA  01749
Correspondent Contact JOHN A CHAVES
Regulation Number878.4800
Classification Product Code
GAA  
Date Received03/26/1990
Decision Date 05/24/1990
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
Predetermined Change
Control Plan Authorized		 No
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