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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 K943405
Device Name STYLE I WRAPPER SUNGLASSES
Applicant
Plastic, Inc.
2101 Lakeview Rd.
P.O. Box 458
Mexico,  MO  65265
Applicant Contact BARBARA J CIRKL
Correspondent
Plastic, Inc.
2101 Lakeview Rd.
P.O. Box 458
Mexico,  MO  65265
Correspondent Contact BARBARA J CIRKL
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/14/1994
Decision Date 08/17/1994
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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