The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Maestro Air Motors.
Device ID | K150801 |
510k Number | K150801 |
Device Name: | Stryker Maestro Air Motors |
Classification | Motor, Drill, Pneumatic |
Applicant | STRYKER CORPORATION 4100 E. MILHAM AVENUE Kalamazoo, MI 49001 |
Contact | Deval Patel |
Correspondent | Deval Patel STRYKER CORPORATION 4100 E. MILHAM AVENUE Kalamazoo, MI 49001 |
Product Code | HBB |
CFR Regulation Number | 882.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-26 |
Decision Date | 2015-05-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613327128727 | K150801 | 000 |
07613327096460 | K150801 | 000 |