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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K881757
Device Name RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
Applicant
DOWNS SURGICAL LTD.
42 INDUSTRIAL WAY
WILMINGTON,  MA  01887
Applicant Contact FORSTER
Correspondent
DOWNS SURGICAL LTD.
42 INDUSTRIAL WAY
WILMINGTON,  MA  01887
Correspondent Contact FORSTER
Regulation Number874.1820
Classification Product Code
ETN  
Date Received04/25/1988
Decision Date 07/15/1988
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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