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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
510(k) Number K811577
Device Name CROUCH CORNEAL PROTECTOR
Applicant
Denver Biomedicals, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Denver Biomedicals, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.4750
Classification Product Code
HOY  
Date Received06/05/1981
Decision Date 08/07/1981
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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