The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Plaster Stand.
Device ID | K870100 |
510k Number | K870100 |
Device Name: | PLASTER STAND |
Classification | Instrument, Cast Application/removal, 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 | LGG |
CFR Regulation Number | 888.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-09 |
Decision Date | 1987-01-28 |