The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Crossflow Day-use Inflow Cassette Tubing And Patient-use Tubing.
| Device ID | K151932 |
| 510k Number | K151932 |
| Device Name: | Stryker CrossFlow Day-Use Inflow Cassette Tubing And Patient-Use Tubing |
| Classification | Arthroscope |
| Applicant | STRYKER CORPORATION 5900 OPTICAL CT San Jose, CA 95138 |
| Contact | Somi Ekwealor |
| Correspondent | Somi Ekwealor STRYKER CORPORATION 5900 OPTICAL CT San Jose, CA 95138 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-14 |
| Decision Date | 2016-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327261036 | K151932 | 000 |
| 37613327261029 | K151932 | 000 |