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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Ear Suction
510(k) Number K853589
Device Name SHAH SELF-CLEARING MASTOID SUCTION TUBE
Applicant
DOWNS SURGICAL LTD.
42 INDUSTRIAL WAY
WILMINGTON,  MA  01887
Applicant Contact JARVIS CRIBB
Correspondent
DOWNS SURGICAL LTD.
42 INDUSTRIAL WAY
WILMINGTON,  MA  01887
Correspondent Contact JARVIS CRIBB
Regulation Number874.4420
Classification Product Code
JZF  
Date Received08/27/1985
Decision Date 12/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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