The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Lead Apron Caddy.
Device ID | K870103 |
510k Number | K870103 |
Device Name: | LEAD APRON CADDY |
Classification | Apron, Leaded |
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 | EAJ |
CFR Regulation Number | 892.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-09 |
Decision Date | 1987-01-21 |