The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Crossfire System.
| Device ID | K071859 |
| 510k Number | K071859 |
| Device Name: | STRYKER CROSSFIRE SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Contact | K. Jeffrey Semone |
| Correspondent | K. Jeffrey Semone Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-05 |
| Decision Date | 2007-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327145205 | K071859 | 000 |
| 07613327060904 | K071859 | 000 |
| 07613327058109 | K071859 | 000 |
| 07613327058093 | K071859 | 000 |
| 07613327058086 | K071859 | 000 |
| 07613327058079 | K071859 | 000 |