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510(k) K911080

HYGIENA-TRACH by Apdyne Medical Co. — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1991
Date Received
March 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Tracheostomy And Tube Cuff
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

Other clearances by Apdyne Medical Co.

  • K894369 — APDYNE PHENOL APPLICATOR KIT (October 12, 1989)

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