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510(k) K884713

COLONIC BALLOON DIALATORS by Primrose Medical, Inc. — Product Code FFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1989
Date Received
November 8, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Rectal
Device Class
Class I
Regulation Number
876.5450
Review Panel
GU
Submission Type

Other clearances by Primrose Medical, Inc.

  • K884711 — URETHRAL AND URETERAL BALLOON DILATATORS (September 29, 1989)
  • K884715 — ACHELASIA BALLOON DIALATOR (September 29, 1989)
  • K884714 — BILIARY DIALATOR (September 29, 1989)
  • K884712 — ESOPHAGEAL AND PYLORIC BALLOON DIALATORS (September 8, 1989)
  • K884709 — ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) (September 8, 1989)
  • K883420 — LANCET, BLOOD (August 26, 1988)
  • K881976 — CATHETER, INTRAVASCULAR (August 4, 1988)
  • K881975 — SET, INTRAVASCULAR (July 29, 1988)
  • K881977 — PRESSURE INFUSOR (July 29, 1988)
  • K881978 — ENTERAL FEEDING TUBES (July 13, 1988)

Other clearances for product code FFP

  • K964634 — ANOKRYO (June 6, 1997)
  • K901426 — COLONIC BALLOON DILATOR (June 21, 1990)
  • K894618 — INAMED RHEMO-D (TM) DILATOR (January 18, 1990)
  • K830354 — COLORECTAL DILATOR (May 27, 1983)