510(k) K781082

CAST BLOCK by Orthopedic Equipment Co., Inc. — Product Code JEB

K781082 is an FDA 510(k) premarket notification submitted by Orthopedic Equipment Co., Inc. for the device "CAST BLOCK". The FDA issued a decision of Substantially Equivalent on July 7, 1978. The device falls under product code JEB (Table, Surgical With Orthopedic Accessories, Manual), a Class I device regulated under 21 CFR 878.4950. Orthopedic Equipment Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1978
Date Received
June 29, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Surgical With Orthopedic Accessories, Manual
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type