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510(k) K830842

OB HELP ARM by Lic-Orthion — Product Code ILE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1983
Date Received
March 17, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sling, Arm, Overhead Supported
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

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  • K843234 — CITOMAT AUTOCLAVES (October 25, 1984)
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Other clearances for product code ILE

  • K823811 — OVERHEAD ARM SLINGS (January 14, 1983)
  • K823152 — OB HELP ARM (November 5, 1982)