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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Weights, Eyelid, External
510(k) Number K971242
Device Name BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
Applicant
Ipax, Inc.
2109 W. Amherst Ave.
Englewood,  CO  80110
Applicant Contact PHIL PENNELL
Correspondent
Ipax, Inc.
2109 W. Amherst Ave.
Englewood,  CO  80110
Correspondent Contact PHIL PENNELL
Regulation Number886.5700
Classification Product Code
MML  
Date Received04/02/1997
Decision Date 12/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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