The following data is part of a premarket notification filed by Bio Protech, Inc. with the FDA for Proplate, Models 9641c, 9641f, P9641c, P9641f, 9642c, 9642f And P9642c.
| Device ID | K092761 |
| 510k Number | K092761 |
| Device Name: | PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BIO PROTECH, INC. 2626 VALLEY VIEW LANE SUITE 4 Dallas, TX 75234 -6274 |
| Contact | Judy Burton |
| Correspondent | Judy Burton BIO PROTECH, INC. 2626 VALLEY VIEW LANE SUITE 4 Dallas, TX 75234 -6274 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-09 |
| Decision Date | 2009-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607151563537 | K092761 | 000 |
| 10607151056350 | K092761 | 000 |
| 10607151001688 | K092761 | 000 |
| 10607151001671 | K092761 | 000 |
| 20612479217472 | K092761 | 000 |
| 20612479217458 | K092761 | 000 |
| 18809083942882 | K092761 | 000 |
| 00607151049973 | K092761 | 000 |