The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for 4mm & 5mm Full Radius Blade Plus, 4mm & 5mm Barrel Bur Plus/4mm Barrel Tornado Bur Plus, 4mm & 5mm Aggressive Blade Plus.
Device ID | K131191 |
510k Number | K131191 |
Device Name: | 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS |
Classification | Arthroscope |
Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Susan Kagan |
Correspondent | Susan Kagan DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-04-26 |
Decision Date | 2013-07-22 |
Summary: | summary |