510(k) K864846

RADIOGRAPHIC - LEG SECTION by American Sterilizer Co. — Product Code KQS

K864846 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "RADIOGRAPHIC - LEG SECTION". The FDA issued a decision of Substantially Equivalent on December 24, 1986. The device falls under product code KQS (Table, Cystometric, Non-Electric And Accessories), a Class I device regulated under 21 CFR 876.4890. American Sterilizer Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1986
Date Received
December 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Cystometric, Non-Electric And Accessories
Device Class
Class I
Regulation Number
876.4890
Review Panel
GU
Submission Type