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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 K945346
Device Name MAKROLON 2405 GOGGLES (LIGHT AND DARK)
Applicant
Universal Massage & Tanning, Inc.
1385 E. Oakland Park Rd.
Ft. Lauderdale,  FL  33334
Applicant Contact ROBERT HOLTMAN
Correspondent
Universal Massage & Tanning, Inc.
1385 E. Oakland Park Rd.
Ft. Lauderdale,  FL  33334
Correspondent Contact ROBERT HOLTMAN
Regulation Number886.4750
Classification Product Code
HOY  
Date Received11/02/1994
Decision Date 11/22/1994
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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