510(k) K873276

EXTENSION DEVICE 1416 by Stierlen-Maquet AG — Product Code JEB

K873276 is an FDA 510(k) premarket notification submitted by Stierlen-Maquet AG for the device "EXTENSION DEVICE 1416". The FDA issued a decision of Substantially Equivalent on September 17, 1987. The device falls under product code JEB (Table, Surgical With Orthopedic Accessories, Manual), a Class I device regulated under 21 CFR 878.4950. Stierlen-Maquet AG has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1987
Date Received
August 17, 1987
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