The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker S2 Drill.
Device ID | K141935 |
510k Number | K141935 |
Device Name: | STRYKER S2 DRILL |
Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
Applicant | STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49001 |
Contact | Vishal Kanani |
Correspondent | Vishal Kanani STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49001 |
Product Code | ERL |
CFR Regulation Number | 874.4250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-17 |
Decision Date | 2014-09-26 |
Summary: | summary |