The following data is part of a premarket notification filed by Resonant Medical, Inc. with the FDA for Restitu.
| Device ID | K041937 |
| 510k Number | K041937 |
| Device Name: | RESTITU |
| Classification | Accelerator, Linear, Medical |
| Applicant | RESONANT MEDICAL, INC. 16787 BERNARDO CENTER DRIVE SUITE A-1 San Diego, CA 92128 |
| Contact | Sean M Curry |
| Correspondent | Sean M Curry RESONANT MEDICAL, INC. 16787 BERNARDO CENTER DRIVE SUITE A-1 San Diego, CA 92128 |
| Product Code | IYE |
| Subsequent Product Code | IWB |
| Subsequent Product Code | KPQ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-19 |
| Decision Date | 2004-11-16 |
| Summary: | summary |