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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 K982599
Device Name THE FREMSTAD RING
Applicant
Ophthalmic Solutions, LLC
2179 Northlake Pkwy., Bldg. 5
Suite 115
Tucker,  GA  30084
Applicant Contact DARIA A FREMSTAD
Correspondent
Ophthalmic Solutions, LLC
2179 Northlake Pkwy., Bldg. 5
Suite 115
Tucker,  GA  30084
Correspondent Contact DARIA A FREMSTAD
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received07/27/1998
Decision Date 02/16/1999
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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