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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 Ct.
Danville,  CA  94506
Applicant Contact EDGAR A RAININ
Correspondent
X-Tech Medical, LLC
111 Wild Oak Ct.
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
Predetermined Change
Control Plan Authorized		 No
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