The following data is part of a premarket notification filed by Nw Radiation Therapy Products with the FDA for Northwest Radiation Therapy Products, Precision Stepper And Guide.
| Device ID | K973786 |
| 510k Number | K973786 |
| Device Name: | NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE |
| Classification | System, Applicator, Radionuclide, Manual |
| Applicant | NW RADIATION THERAPY PRODUCTS 5245 SHILSHOLE AVENUE NW, SUITE B Seattle,, WA 98107 |
| Contact | Terence Ellard |
| Correspondent | Terence Ellard NW RADIATION THERAPY PRODUCTS 5245 SHILSHOLE AVENUE NW, SUITE B Seattle,, WA 98107 |
| Product Code | IWJ |
| CFR Regulation Number | 892.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-06 |
| Decision Date | 1998-01-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852656007489 | K973786 | 000 |
| 00852656007229 | K973786 | 000 |
| 00852656007212 | K973786 | 000 |
| 00852656007205 | K973786 | 000 |
| 00852656007199 | K973786 | 000 |
| 00852656007182 | K973786 | 000 |
| 00852656007175 | K973786 | 000 |
| 00852656007168 | K973786 | 000 |
| 00852656007151 | K973786 | 000 |
| 00852656007144 | K973786 | 000 |
| 00852656007137 | K973786 | 000 |
| 00852656007120 | K973786 | 000 |
| 00852656007113 | K973786 | 000 |
| 00852656007106 | K973786 | 000 |
| 00852656007090 | K973786 | 000 |
| 00852656007083 | K973786 | 000 |
| 00852656007236 | K973786 | 000 |
| 00852656007243 | K973786 | 000 |
| 00852656007250 | K973786 | 000 |
| 00852656007403 | K973786 | 000 |
| 00852656007397 | K973786 | 000 |
| 00852656007380 | K973786 | 000 |
| 00852656007373 | K973786 | 000 |
| 00852656007366 | K973786 | 000 |
| 00852656007359 | K973786 | 000 |
| 00852656007342 | K973786 | 000 |
| 00852656007335 | K973786 | 000 |
| 00852656007328 | K973786 | 000 |
| 00852656007311 | K973786 | 000 |
| 00852656007304 | K973786 | 000 |
| 00852656007298 | K973786 | 000 |
| 00852656007281 | K973786 | 000 |
| 00852656007274 | K973786 | 000 |
| 00852656007267 | K973786 | 000 |
| 00852656007519 | K973786 | 000 |