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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 (Other Material) - Daily
510(k) Number K002703
Device Name O-PERM 30
Applicant
Optical Polymer Research, Inc.
5921 NE 38th St.
Gainesville,  FL  32609
Applicant Contact WERNER P SCHUMAN
Correspondent
Optical Polymer Research, Inc.
5921 NE 38th St.
Gainesville,  FL  32609
Correspondent Contact WERNER P SCHUMAN
Regulation Number886.5916
Classification Product Code
HQD  
Date Received08/30/2000
Decision Date 11/21/2000
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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