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510(k) K001328

INTRODUCER SHEATH by Novasys Medical, Inc. — Product Code FEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2000
Date Received
April 26, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Obturator, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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  • K001150 — ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 (June 29, 2000)
  • K001151 — ELECTROSURGICAL ELECTRODE FAMILY (June 27, 2000)

Other clearances for product code FEC

  • K760172 — OBTURATOR, VISUAL (December 2, 1976)
  • K760183 — OBTURATOR, DEFLECTING (December 2, 1976)