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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 K923375
Device Name PLAYSKOOL SUNGLASSES
Applicant
Playtime Products, Inc.
601 Thirteenth St. NW
Washington,  DC  20005
Applicant Contact TERRY G MAHN
Correspondent
Playtime Products, Inc.
601 Thirteenth St. NW
Washington,  DC  20005
Correspondent Contact TERRY G MAHN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/09/1992
Decision Date 06/09/1993
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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