The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Interpulse Handpiece Set, Splash Shields, Irrigation And Suction Tips, Rechargeable Battery Pack.
| Device ID | K972069 |
| 510k Number | K972069 |
| Device Name: | STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK |
| Classification | Lavage, Jet |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Tammmy Lounds |
| Correspondent | Tammmy 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 | 1997-06-03 |
| Decision Date | 1997-07-29 |
| Summary: | summary |