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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 K000485
Device Name HYDRO2, HS-75
Applicant
INNOVISION, INC.
3125 SOUTH 61ST AVE.
OMAHA,  NE  68106 -3675
Applicant Contact DON M WOODFORD
Correspondent
INNOVISION, INC.
3125 SOUTH 61ST AVE.
OMAHA,  NE  68106 -3675
Correspondent Contact DON M WOODFORD
Regulation Number886.5916
Classification Product Code
HQD  
Date Received02/14/2000
Decision Date 05/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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