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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brush, Cleaning, Tracheal Tube
510(k) Number K862563
Device Name TRACHEOSTOMY CLEANSING SOLUTION
Applicant
Clinipad Corp.
66 High St.
P.O. Box 387
Guilford,  CT  06437
Applicant Contact SIDNEY FINKELSTEIN
Correspondent
Clinipad Corp.
66 High St.
P.O. Box 387
Guilford,  CT  06437
Correspondent Contact SIDNEY FINKELSTEIN
Regulation Number868.5795
Classification Product Code
EPE  
Date Received07/03/1986
Decision Date 07/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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