510(k) K811343

HUMERAL FRACTURE CAST BRACE by Deseret Medical, Inc. — Product Code IQI

K811343 is an FDA 510(k) premarket notification submitted by Deseret Medical, Inc. for the device "HUMERAL FRACTURE CAST BRACE". The FDA issued a decision of Substantially Equivalent on May 28, 1981. The device falls under product code IQI (Orthosis, Limb Brace), a Class I device regulated under 21 CFR 890.3475. Deseret Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1981
Date Received
May 12, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Limb Brace
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type