510(k) K813627

BK-6453 RIMMED ACRYLIC LAP TRAY KIT by Fred Sammons, Inc. — Product Code KNO

K813627 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "BK-6453 RIMMED ACRYLIC LAP TRAY KIT". The FDA issued a decision of Substantially Equivalent on January 19, 1982. The device falls under product code KNO (Accessories, Wheelchair), a Class I device regulated under 21 CFR 890.3910. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1982
Date Received
December 29, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Wheelchair
Device Class
Class I
Regulation Number
890.3910
Review Panel
PM
Submission Type