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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 K872659
Device Name TAPELESS EYE SHIELD
Applicant
Precision Therapeutics, Inc.
2927 S. Industrial Rd.
Las Vegas,  NV  89109
Applicant Contact LEONARDI, M.D.
Correspondent
Precision Therapeutics, Inc.
2927 S. Industrial Rd.
Las Vegas,  NV  89109
Correspondent Contact LEONARDI, M.D.
Regulation Number886.4750
Classification Product Code
HOY  
Date Received07/07/1987
Decision Date 07/27/1987
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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