The following data is part of a premarket notification filed by Rosses Medical Systems with the FDA for Strata, Model V.o.95.
| Device ID | K981678 |
| 510k Number | K981678 |
| Device Name: | STRATA, MODEL V.O.95 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | ROSSES MEDICAL SYSTEMS 10620 GUILFORD RD., STE. 201 Jessup, MD 20794 |
| Contact | Rene Spector |
| Correspondent | Rene Spector ROSSES MEDICAL SYSTEMS 10620 GUILFORD RD., STE. 201 Jessup, MD 20794 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-12 |
| Decision Date | 1998-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852656007052 | K981678 | 000 |