510(k) K823641

BATHING CHAIR FOR CHILD by Fred Sammons, Inc. — Product Code ILS

K823641 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "BATHING CHAIR FOR CHILD". The FDA issued a decision of Substantially Equivalent on January 21, 1983. The device falls under product code ILS (Adaptor, Hygiene), 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 21, 1983
Date Received
December 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Hygiene
Device Class
Class I
Regulation Number
890.5050
Review Panel
PM
Submission Type