510(k) K831309

DELIVERY 4 TABLE by Amsco Co. — Product Code KNC

K831309 is an FDA 510(k) premarket notification submitted by Amsco Co. for the device "DELIVERY 4 TABLE". The FDA issued a decision of Substantially Equivalent on June 15, 1983. The device falls under product code KNC (Table, Obstetric (And Accessories)), a Class II device regulated under 21 CFR 884.4900. Amsco Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1983
Date Received
April 22, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Obstetric (And Accessories)
Device Class
Class II
Regulation Number
884.4900
Review Panel
OB
Submission Type