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510(k) K931048

4-SURE NELATON CATHETER by Boston Pacific Medical, Inc. — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1994
Date Received
March 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Boston Pacific Medical, Inc.

  • K933109 — 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS (March 28, 1994)
  • K922402 — 4 SURE TM ENTERAL FEEDING BAG (March 25, 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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