The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Strykeflow Suction Irrigator (modification).
| Device ID | K954726 |
| 510k Number | K954726 |
| Device Name: | STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Charles L Nelson |
| Correspondent | Charles L Nelson Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-03 |
| Decision Date | 1995-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327061407 | K954726 | 000 |
| 37613327061360 | K954726 | 000 |