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510(k) K922401

4 SURE TM COLOSTOMY POUCH by Boston Pacific Medical, Inc. — Product Code EZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1992
Date Received
May 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pouch, Colostomy
Device Class
Class I
Regulation Number
876.5900
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)
  • 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)

Other clearances for product code EZQ

  • K111365 — VITALA CONTINENCE CONTROL DEVICE (August 19, 2011)
  • K102536 — VITALA CONTINENCE CONTROL DEVICE (December 1, 2010)
  • K083785 — VITALA CONTINENCE CONTROL DEVICE (April 2, 2010)
  • K880327 — MARLEN ULTRA ILEOSTOMY POUCH-5000 (February 19, 1988)
  • K863830 — CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM (October 16, 1986)