510(k) K823772

AMSCO ORTHOGRAPHIC 2 TABLE by American Sterilizer Co. — Product Code BWN

K823772 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "AMSCO ORTHOGRAPHIC 2 TABLE". The FDA issued a decision of Substantially Equivalent on January 14, 1983. The device falls under product code BWN (Table And Attachments, Operating-Room), 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
January 14, 1983
Date Received
December 14, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table And Attachments, Operating-Room
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type