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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collagen Corneal Shield
510(k) Number K896449
Device Name IM COLLAGEN SHIELD
Applicant
Intermedical, Inc.
1101 Knollwood Dr.
Safety Harbor,  FL  34695
Applicant Contact RON THERIOT
Correspondent
Intermedical, Inc.
1101 Knollwood Dr.
Safety Harbor,  FL  34695
Correspondent Contact RON THERIOT
Regulation Number886.4750
Classification Product Code
MOE  
Date Received11/09/1989
Decision Date 05/24/1990
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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