The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Precision Thin Reciprocating Blade, 0.010in..
| Device ID | K161514 |
| 510k Number | K161514 |
| Device Name: | Precision Thin Reciprocating Blade, 0.010in. |
| Classification | Bur, Ear, Nose And Throat |
| Applicant | STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49009 |
| Contact | Joanna Mccarthy |
| Correspondent | Joanna Mccarthy STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49009 |
| Product Code | EQJ |
| CFR Regulation Number | 874.4140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-02 |
| Decision Date | 2017-01-17 |
| Summary: | summary |