FDA Device Info: Anondyne Docs and Info
FDA Device Info: Anondyne Docs and Info
Complete copy of the following: 1. Any and all Warning Letters to Restorative Products, Inc., including but not limited to FLA-06-08, relating to any product manufactured or sold by the company; 2. Any and all responses to any Warning Letters identified or related to #1 above; 3. Any and all 510K Clearance Letters provided to Restorative Products, Inc.; 4. Any and all 510K Clearance Letters provided to Restorative Products, Inc., related to any ANONDYNE THERAPY SYSTEM; 5. Any and all WARNING LETTERS related to any ANODYNE THERAPY SYSTEMS related to 1-4 above. [REQ YEAR: 2022]
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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