510(k) K813629

BK-6111 HI-D TRANSFER BOARD by Fred Sammons, Inc. — Product Code IKX

K813629 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "BK-6111 HI-D TRANSFER BOARD". The FDA issued a decision of Substantially Equivalent on January 19, 1982. The device falls under product code IKX (Aid, Transfer), a Class I device regulated under 21 CFR 890.5050. 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
Aid, Transfer
Device Class
Class I
Regulation Number
890.5050
Review Panel
PM
Submission Type