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510(k) K810877

ORTHOSIS BANDAGES by Ortho-Cast, Inc. — Product Code ITG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1981
Date Received
March 31, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Cast
Device Class
Class I
Regulation Number
890.3025
Review Panel
PM
Submission Type

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  • K832237 — ORTHOPEDIC CASTING TAPE MAXCAST (August 16, 1983)
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  • K820890 — URETHANE ORTHOPAEDIC CASTING TAPE (June 23, 1982)