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510(k) K971411

DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K by Bentec Medical, Inc. — Product Code EMX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1997
Date Received
April 16, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Balloon, Epistaxis
Device Class
Class I
Regulation Number
874.4100
Review Panel
EN
Submission Type

Other clearances by Bentec Medical, Inc.

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  • K983276 — HYDROFERA BACTERISTATIC NASAL DRESSING (September 14, 1999)
  • K982731 — MEROGEL NASAL DRESSING AND SINUS STENT (February 2, 1999)
  • K984069 — ENTAXIS NASAL PACKING (January 25, 1999)
  • K981966 — NOSEBLEED NOSECLIP (August 14, 1998)
  • K973656 — DISPOSABLE SILICONE EPISTAXIS CATHETER (November 18, 1997)
  • K973085 — ULTRACELL PACKING WITH SLEEVE (November 18, 1997)