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510(k) K982128

SHIKANI-FRENCH SPEAKING VALVE by Pilling Weck Surgical — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1998
Date Received
June 17, 1998
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

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  • K990935 — JACKSON ESOPHAGEAL DILATOR (May 17, 1999)
  • K990561 — OPTICAL FORCEPS (May 14, 1999)

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