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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 PARKWAY,
EUDORA,  KS 
Applicant Contact AL BOEDEKER
Correspondent
M-PACT CORP.
1040 0CL PARKWAY,
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
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