The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Osi Rizzoli Orthopedic Table/manual Version.
Device ID | K880263 |
510k Number | K880263 |
Device Name: | OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION |
Classification | Table, Surgical With Orthopedic Accessories, Manual |
Applicant | ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
Contact | Robert R Moore |
Correspondent | Robert R Moore ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
Product Code | JEB |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-22 |
Decision Date | 1988-03-15 |