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510(k) K933109

4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS by Boston Pacific Medical, Inc. — Product Code KOD

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
March 28, 1994
Date Received
June 25, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Boston Pacific Medical, Inc.

  • K922402 — 4 SURE TM ENTERAL FEEDING BAG (March 25, 1994)
  • K931048 — 4-SURE NELATON CATHETER (February 14, 1994)
  • K931047 — 4-SURE FEMALE CATHETER (February 14, 1994)
  • K921852 — 4 SURE TM RECTAL TUBE (October 8, 1993)
  • K921853 — 4 SURE TM FEEDING TUBES (July 13, 1993)
  • K921851 — 4 SURE TM SUCTION CATHETERS & KITS (July 7, 1993)
  • K922398 — 4 SURE TM ENEMA BAG SET (June 17, 1993)
  • K922397 — 4 SURE TM NASAL OXYGEN CANNULA (March 18, 1993)
  • K924995 — 4 SURE TM ANESTHESIA EXTENSION SET (December 30, 1992)
  • K922401 — 4 SURE TM COLOSTOMY POUCH (June 10, 1992)

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