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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 K896084
Device Name MICROSPEARS
Applicant
Sparta Surgical Corp.
26602 Corporate Ave.
Hayward,  CA  94545
Applicant Contact CINDY WILSON
Correspondent
Sparta Surgical Corp.
26602 Corporate Ave.
Hayward,  CA  94545
Correspondent Contact CINDY WILSON
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received10/19/1989
Decision Date 11/02/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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