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510(k) K990376

BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME by Ballard Medical Products — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1999
Date Received
February 8, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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  • K964369 — TRACH CARE SET WITH MICROBAN (February 11, 1997)
  • K951533 — EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT (July 5, 1995)
  • K923487 — BAL CATH (July 30, 1993)

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