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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 K993883
Device Name M-PACT CORNEAL LIGHT SHIELD
Applicant
M-Pact Corp.
1040 0cl Pkwy.,
Eudora,  KS 
Applicant Contact AL BOEDEKER
Correspondent
M-Pact Corp.
1040 0cl Pkwy.,
Eudora,  KS 
Correspondent Contact AL BOEDEKER
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received11/15/1999
Decision Date 12/21/1999
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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