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510(k) K821256

COUNTER-ROTATION SYSTEM by The Langer Group — Product Code ITN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1982
Date Received
April 30, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Denis Brown
Device Class
Class I
Regulation Number
890.3675
Review Panel
PM
Submission Type

Other clearances by The Langer Group

  • K821255 — ELECTRODYNOGRAM SYSTEM (July 2, 1982)

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