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510(k) K071579

PEF TUBE by N.M. Beale Co., Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2007
Date Received
June 8, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

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

  • K093584 — EZ-MISTER (March 4, 2011)
  • K093329 — SCOPE INTRODUCER MODEL 7400 (February 16, 2010)
  • K992178 — BALLOON FOR ULTRASONIC ENDOSCOPES (May 12, 2000)
  • K903834 — N. M. BEALE COMPANY VU-THRU WATER BOTTLE (September 24, 1990)

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  • K241169 — Entarik NI Feeding Tube System (November 22, 2024)
  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
  • K240965 — CORTRAK* 2 Enteral Access System (20-0950) (June 6, 2024)
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