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510(k) K955634

MONTGOMERY TRACHEOSTOMY SPEAKING VALVE by Boston Medical Products, Inc. — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1996
Date Received
December 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

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  • K972092 — NASAL AIRWAY SPLINT (July 8, 1997)
  • K972151 — DOYLE COMBO NASAL AIRWAY SPLINT (July 7, 1997)
  • K972082 — CUSTOM NASAL SPLINT (July 3, 1997)
  • K972060 — NASAL SEPTAL BUTTON (July 3, 1997)
  • K972077 — EPI-STOP EPISTAXIS CATHETER (June 26, 1997)

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