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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cup, Eye
510(k) Number K971134
Device Name VISTA EYESHOWER
Applicant
John Branch
3722 Ave., Sausalito
Irvine,  CA  92606
Applicant Contact GRACE HOLLAND
Correspondent
John Branch
3722 Ave., Sausalito
Irvine,  CA  92606
Correspondent Contact GRACE HOLLAND
Classification Product Code
LXQ  
Date Received03/28/1997
Decision Date 11/04/1997
Decision Substantially Equivalent (SESE)
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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