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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 K972416
Device Name MOMO DESIGN OR MOMO
Applicant
Momo U.S.A., Inc.
2100 NW 93rd. Ave.
Miami,  FL  33172
Applicant Contact PHILIP MOORE
Correspondent
Momo U.S.A., Inc.
2100 NW 93rd. Ave.
Miami,  FL  33172
Correspondent Contact PHILIP MOORE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/27/1997
Decision Date 07/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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