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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Vestibular Analysis
510(k) Number K911795
Device Name KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)
Applicant
Breg, Inc.
344 22nd St.
Costa Mesa,  CA  92627
Applicant Contact NANCY A WILLCOX
Correspondent
Breg, Inc.
344 22nd St.
Costa Mesa,  CA  92627
Correspondent Contact NANCY A WILLCOX
Classification Product Code
LXV  
Date Received04/22/1991
Decision Date 11/19/1991
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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