The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Aria Pneumatic System.
Device ID | K061725 |
510k Number | K061725 |
Device Name: | STRYKER ARIA PNEUMATIC SYSTEM |
Classification | Motor, Drill, Pneumatic |
Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
Contact | Valerie Franck |
Correspondent | Valerie Franck STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
Product Code | HBB |
CFR Regulation Number | 882.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-19 |
Decision Date | 2006-10-26 |