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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 K942533
FOIA Releasable 510(k) K942533
Device Name NOVALENS/NOVAWET PERCEPTION AND VANGUARD
Applicant
OCUTEC CORPORATION, INC.
2700-200 GATEWAY CENTER BLVD.
MORRISVILLE,  NC  27560
Applicant Contact ALAN J TOUCH
Correspondent
OCUTEC CORPORATION, INC.
2700-200 GATEWAY CENTER BLVD.
MORRISVILLE,  NC  27560
Correspondent Contact ALAN J TOUCH
Regulation Number886.5916
Classification Product Code
HQD  
Date Received05/27/1994
Decision Date 08/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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