The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Single Amplifier For Botox.
Device ID | K051852 |
510k Number | K051852 |
Device Name: | SINGLE AMPLIFIER FOR BOTOX |
Classification | Amplifier, Physiological Signal |
Applicant | ALLERGAN, INC. 2525 DUPONT DR. Irvine, CA 92612 |
Contact | Susan O'brien |
Correspondent | Susan O'brien ALLERGAN, INC. 2525 DUPONT DR. Irvine, CA 92612 |
Product Code | GWL |
CFR Regulation Number | 882.1835 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-08 |
Decision Date | 2005-09-14 |