SINGLE AMPLIFIER FOR BOTOX

Amplifier, Physiological Signal

ALLERGAN, INC.

The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Single Amplifier For Botox.

Pre-market Notification Details

Device IDK051852
510k NumberK051852
Device Name:SINGLE AMPLIFIER FOR BOTOX
ClassificationAmplifier, Physiological Signal
Applicant ALLERGAN, INC. 2525 DUPONT DR. Irvine,  CA  92612
ContactSusan O'brien
CorrespondentSusan O'brien
ALLERGAN, INC. 2525 DUPONT DR. Irvine,  CA  92612
Product CodeGWL  
CFR Regulation Number882.1835 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-08
Decision Date2005-09-14

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