The following data is part of a premarket notification filed by Prowess, Inc. with the FDA for Puma Model Version 1.0.
| Device ID | K100801 |
| 510k Number | K100801 |
| Device Name: | PUMA MODEL VERSION 1.0 |
| Classification | Accelerator, Linear, Medical |
| Applicant | PROWESS, INC. 1844 CLAYTON ROAD Concord, CA 94520 |
| Contact | Rachel Scarano |
| Correspondent | Rachel Scarano PROWESS, INC. 1844 CLAYTON ROAD Concord, CA 94520 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-22 |
| Decision Date | 2010-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859032007095 | K100801 | 000 |