The following data is part of a premarket notification filed by Spark Biomedical, Inc. with the FDA for Sparrow Therapy System.
| Device ID | K201873 |
| 510k Number | K201873 |
| Device Name: | Sparrow Therapy System |
| Classification | Percutaneous Nerve Stimulator For Opioid Withdrawal |
| Applicant | Spark Biomedical, Inc. 18208 Preston Road, Suite D9-531 Dallas, TX 75252 |
| Contact | Daniel Powell |
| Correspondent | Michelle Rubin-onur AcKnowledge Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego, CA 92110 |
| Product Code | PZR |
| CFR Regulation Number | 882.5896 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-07 |
| Decision Date | 2021-01-02 |