The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for Johnson And Johnson Power System.
Device ID | K913629 |
510k Number | K913629 |
Device Name: | JOHNSON AND JOHNSON POWER SYSTEM |
Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
Applicant | JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham, MA 02767 |
Contact | Marsha J Stone |
Correspondent | Marsha J Stone JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham, MA 02767 |
Product Code | HSZ |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-15 |
Decision Date | 1991-11-13 |