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510(k) K180552

Modified Novy Cornual Cannulation Set by Cook Incorporated — Product Code MOV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2018
Date Received
March 1, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheters, Salpingography
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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Other clearances for product code MOV

  • K932436 — ECHOMARK INTRAUTERINE GUIDING CATHETER (November 16, 1995)
  • K953314 — CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM (July 28, 1995)
  • K931476 — NOVY CORNUAL CANNULATION SET (July 28, 1995)
  • K931534 — OVAMED INTRAUTERINE ACCESS CATHETER (July 28, 1995)