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510(k) K820469

WARM & FORM KNEE SUPPORTS by Thermo-Mold Medical Products, Inc. — Product Code IQI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1982
Date Received
February 22, 1982
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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