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510(k) K921852

4 SURE TM RECTAL TUBE by Boston Pacific Medical, Inc. — Product Code KMO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1993
Date Received
April 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Binder, Elastic
Device Class
Class I
Regulation Number
880.5160
Review Panel
HO
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)
  • 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)

Other clearances for product code KMO

  • K893809 — COUGH PILLOW (August 28, 1989)
  • K883214 — THORACIC SUPPORT SYSTEM (January 17, 1989)
  • K882592 — HEART HUGGER STERNUM SUPPORT HARNESS (September 20, 1988)
  • K792629 — STERILIZATION PROCESS/T-BINDER (January 11, 1980)