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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spectacle, Magnifying
510(k) Number K844716
Device Name MAGNIFYING SPECTACLES W/PLASTIC LENSES
Applicant
Gazelle Corp.
72-9 Jen Ai Rd., Sec. 2
Taipei,  TW
Applicant Contact PAUL HUANG
Correspondent
Gazelle Corp.
72-9 Jen Ai Rd., Sec. 2
Taipei,  TW
Correspondent Contact PAUL HUANG
Regulation Number886.5840
Classification Product Code
HOI  
Date Received12/04/1984
Decision Date 01/03/1985
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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