Single Amplifier for Botox
FDA 510(k) K051852 · Allergan, Inc.
510(k) numberK051852
Submission
- Device name
- Single Amplifier for Botox
- Applicant
- Allergan, Inc.
Irvine, CA, US - Received
- July 8, 2005
- Decision date
- September 14, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Single Amplifier for Botox cleared by the FDA?
Single Amplifier for Botox (K051852) received a 510(k) decision of Substantially Equivalent on September 14, 2005, 68 days after the submission was received.
What is the product code of K051852?
The FDA product code is GWL – Amplifier, Physiological Signal, a Class II (moderate risk) device regulated under 21 CFR 882.1835.