The following data is part of a premarket notification filed by Stryker Corporate with the FDA for Profess Software, Profess Curved 70 (degrees) Suction, Profess Curved 70 (degrees) Suction, Profess Curved 90 (degrees).
| Device ID | K141551 |
| 510k Number | K141551 |
| Device Name: | PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES) |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | STRYKER CORPORATE 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Becky Ditty |
| Correspondent | Becky Ditty STRYKER CORPORATE 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | PGW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-11 |
| Decision Date | 2014-09-08 |
| Summary: | summary |