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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Ent
510(k) Number K853588
Device Name FIBRELIGHT NASAL SPECULA
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 Number878.1800
Classification Product Code
EPY  
Date Received08/27/1985
Decision Date 12/18/1985
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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