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 |