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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sponge, ophthalmic
510(k) Number K850340
Device Name EYE PROCEDURE PACK
Applicant
MARWOOD MEDICAL, INC.
BOX 8712
GREENSBORO,  NC  27410
Applicant Contact DENISE RANCK
Correspondent
MARWOOD MEDICAL, INC.
BOX 8712
GREENSBORO,  NC  27410
Correspondent Contact DENISE RANCK
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received01/28/1985
Decision Date 05/22/1985
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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