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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 K912367
Device Name EYE BUBBLE
Applicant
Aaron Medical Industries
1640 Central Ave.
St. Petersburg,  FL  33712
Applicant Contact ROBERT SARON
Correspondent
Aaron Medical Industries
1640 Central Ave.
St. Petersburg,  FL  33712
Correspondent Contact ROBERT SARON
Regulation Number886.4750
Classification Product Code
HOY  
Date Received05/29/1991
Decision Date 10/02/1991
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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