The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Interpulse Handpiece Set, Irrigation Tips, Splash Shields, Canal Vision Tip, Irrigation & Suction Tips.
| Device ID | K951666 |
| 510k Number | K951666 |
| Device Name: | STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL VISION TIP, IRRIGATION & SUCTION TIPS |
| Classification | Lavage, Jet |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Tammy Lounds |
| Correspondent | Tammy Lounds STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-10 |
| Decision Date | 1995-09-19 |