The following data is part of a premarket notification filed by Orthopedic Equipment Co., Inc. with the FDA for Cast Block.
Device ID | K781082 |
510k Number | K781082 |
Device Name: | CAST BLOCK |
Classification | Table, Surgical With Orthopedic Accessories, Manual |
Applicant | ORTHOPEDIC EQUIPMENT CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JEB |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-06-29 |
Decision Date | 1978-07-07 |