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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 K780987
Device Name SOFT SILICONE ELASTOMER SPONGE EXPLANT
Applicant
Medical Instrument Research Assoc., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medical Instrument Research Assoc., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received06/14/1978
Decision Date 09/28/1978
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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