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510(k) K811343

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

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

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  • K894033 — DISPOSABLE CATHETER PRESSURE TRANSDUCER (October 17, 1989)
  • K893406 — DESERET PRN ADAPTER (June 22, 1989)
  • K882797 — LUER-LOK MULTIFLO ADAPTER (July 18, 1988)

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  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (June 24, 1983)
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  • K823812 — VARIOUS SUPPORTS AND SPLINTS (January 14, 1983)
  • K823113 — BRACE-UP ALL PURPOSE WRIST BAND (November 16, 1982)