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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 K990671
Device Name DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE
Applicant
HURRICANE MEDICAL
2331K 63RD AVE. EAST
BRADENTON,  FL  34203
Applicant Contact DAVID A CLAPP
Correspondent
HURRICANE MEDICAL
2331K 63RD AVE. EAST
BRADENTON,  FL  34203
Correspondent Contact DAVID A CLAPP
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received03/02/1999
Decision Date 05/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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