The following data is part of a premarket notification filed by Masep Med Science & Tech. Development (shenzhen) C with the FDA for Masep Srrs Gamma Rays Stereotactic Radiation Therapy System For Heads (masep Gamma Therapy System).
| Device ID | K041125 |
| 510k Number | K041125 |
| Device Name: | MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | MASEP MED SCIENCE & TECH. DEVELOPMENT (SHENZHEN) C 55 NORTHERN BLVD., STE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk MASEP MED SCIENCE & TECH. DEVELOPMENT (SHENZHEN) C 55 NORTHERN BLVD., STE 200 Great Neck, NY 11021 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-30 |
| Decision Date | 2004-12-30 |