510(k) K951419

FLEX D-4000 by U.S. Table, Inc. — Product Code INQ

K951419 is an FDA 510(k) premarket notification submitted by U.S. Table, Inc. for the device "FLEX D-4000". The FDA issued a decision of Substantially Equivalent on June 30, 1995. The device falls under product code INQ (Table, Powered), a Class I device regulated under 21 CFR 890.3760. U.S. Table, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1995
Date Received
March 28, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Powered
Device Class
Class I
Regulation Number
890.3760
Review Panel
PM
Submission Type