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510(k) K962240

MOORE TRACHEOSTOMY TUBE by Boston Medical Products, Inc. — Product Code BTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1996
Date Received
June 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheostomy (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

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  • K972082 — CUSTOM NASAL SPLINT (July 3, 1997)
  • K972060 — NASAL SEPTAL BUTTON (July 3, 1997)
  • K972076 — EPI-MAX EPISTAXIS CATHETER (June 26, 1997)

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