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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K051852
Device Name SINGLE AMPLIFIER FOR BOTOX
Applicant
Allergan, Inc.
2525 Dupont Dr.
Irvine,  CA  92612
Applicant Contact SUSAN O'BRIEN
Correspondent
Allergan, Inc.
2525 Dupont Dr.
Irvine,  CA  92612
Correspondent Contact SUSAN O'BRIEN
Regulation Number882.1835
Classification Product Code
GWL  
Date Received07/08/2005
Decision Date 09/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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