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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 K990749
Device Name SOF-SUCTION FLUID EVACUATION SYSTEM
Applicant
X-TECH MEDICAL, LLC.
111 WILD OAK COURT
DANVILLE,  CA  94506
Applicant Contact EDGAR A RAININ
Correspondent
X-TECH MEDICAL, LLC.
111 WILD OAK COURT
DANVILLE,  CA  94506
Correspondent Contact EDGAR A RAININ
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received03/08/1999
Decision Date 04/02/1999
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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