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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 K946016
Device Name IVALON OPHTHALMIC SPONGE
Applicant
Ivalon
5374 Linda Vista Rd., Suite C
San Diego,  CA  92110
Applicant Contact ELIZABETH J MELARAGNO
Correspondent
Ivalon
5374 Linda Vista Rd., Suite C
San Diego,  CA  92110
Correspondent Contact ELIZABETH J MELARAGNO
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received12/09/1994
Decision Date 03/22/1995
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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