510(k) K905816

ORTHOVISION TABLE by American Sterilizer Co. — Product Code JEB

K905816 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "ORTHOVISION TABLE". The FDA issued a decision of Substantially Equivalent on March 6, 1991. The device falls under product code JEB (Table, Surgical With Orthopedic Accessories, Manual), a Class I device regulated under 21 CFR 878.4950. American Sterilizer Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1991
Date Received
December 28, 1990
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