The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Dekompressor Percutaneous Discectomy Probe.
Device ID | K032473 |
510k Number | K032473 |
Device Name: | DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE |
Classification | Arthroscope |
Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
Contact | Robin L Rowe |
Correspondent | Robin L Rowe STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-08-12 |
Decision Date | 2003-11-07 |
Summary: | summary |