The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Jackson Multipurpose Operating Table.
Device ID | K910736 |
510k Number | K910736 |
Device Name: | JACKSON MULTIPURPOSE OPERATING TABLE |
Classification | Table, Surgical With Orthopedic Accessories, Ac-powered |
Applicant | ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
Contact | Robert Moore |
Correspondent | Robert Moore ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
Product Code | JEA |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-21 |
Decision Date | 1991-05-21 |