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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K853790
Device Name BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER
Applicant
Rocky Mountain Medical Corp.
5680 S. Syracuse Cir.
P.O. Box 4783
Greenwood Village,  CO  80111
Applicant Contact RICHARD ROSEBAUM
Correspondent
Rocky Mountain Medical Corp.
5680 S. Syracuse Cir.
P.O. Box 4783
Greenwood Village,  CO  80111
Correspondent Contact RICHARD ROSEBAUM
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/10/1985
Decision Date 10/04/1985
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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