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510(k) K093329

SCOPE INTRODUCER MODEL 7400 by N.M. Beale Co., Inc. — Product Code ODC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2010
Date Received
October 26, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Channel Accessory
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To give the endoscope channel additional or improved functionality.

Other clearances by N.M. Beale Co., Inc.

  • K093584 — EZ-MISTER (March 4, 2011)
  • K071579 — PEF TUBE (November 20, 2007)
  • K992178 — BALLOON FOR ULTRASONIC ENDOSCOPES (May 12, 2000)
  • K903834 — N. M. BEALE COMPANY VU-THRU WATER BOTTLE (September 24, 1990)

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