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510(k) K960231

SPHINCTEROTOME by Lighthouse Medical, Inc. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1996
Date Received
January 17, 1996
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

Other clearances by Lighthouse Medical, Inc.

  • K961049 — FLEX NEEDLE (September 18, 1996)
  • K960230 — SNARE (July 31, 1996)
  • K954121 — CYTOLOGY BRUSH (October 7, 1995)

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