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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Ophthalmic
510(k) Number K842697
Device Name ROOTMAN ORBITAL SURGERY INSTRUMENT SET
Applicant
DOWNS SURGICAL LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DOWNS SURGICAL LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.4350
Classification Product Code
HNR  
Date Received07/11/1984
Decision Date 08/07/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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