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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact (Orthokeratology)
510(k) Number K003933
Device Name BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
Applicant
Polymer Technology
1400 N. Goodman St.
Rochester,  NY  14603
Applicant Contact NANCY ABRAHAM
Correspondent
Polymer Technology
1400 N. Goodman St.
Rochester,  NY  14603
Correspondent Contact NANCY ABRAHAM
Regulation Number886.5916
Classification Product Code
MUW  
Subsequent Product Code
HQD  
Date Received12/20/2000
Decision Date 02/16/2001
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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