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FDA 510(k)

COLONIC BALLOON DIALATORS

K-Number: K884713 · 1989-09-29

ApplicantPrimrose Medical, Inc.
Decision Date1989-09-29
Product CodeFFP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLONIC BALLOON DIALATORS is the device name listed in this FDA 510(k) record. The listed applicant is Primrose Medical, Inc.. It received FDA 510(k) clearance on 1989-09-29 under 510(k) number K884713. The device is classified under product code FFP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLONIC BALLOON DIALATORS?

COLONIC BALLOON DIALATORS is a medical device that received FDA 510(k) clearance on 1989-09-29. The listed applicant is Primrose Medical, Inc.. The 510(k) number is K884713.

When did COLONIC BALLOON DIALATORS receive FDA 510(k) clearance?

COLONIC BALLOON DIALATORS received FDA 510(k) clearance on 1989-09-29, under 510(k) number K884713.

Who is the listed applicant for COLONIC BALLOON DIALATORS?

The FDA 510(k) record lists Primrose Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLONIC BALLOON DIALATORS?

The FDA product code for COLONIC BALLOON DIALATORS is FFP.

Related Clinical Trials

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Other records listing Primrose Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K884714BILIARY DIALATORK884715ACHELASIA BALLOON DIALATORK884711URETHRAL AND URETERAL BALLOON DILATATORSK884712ESOPHAGEAL AND PYLORIC BALLOON DIALATORSK884709ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)K883420LANCET, BLOOD

View all 14 devices →

Related Devices (Code: FFP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K964634ANOKRYOMk Conquest Intl., Inc.K901426COLONIC BALLOON DILATORTelemed Systems, Inc.K894618INAMED RHEMO-D (TM) DILATORInamed Development Co.K830354COLORECTAL DILATORCleveland Medical Supply & Services

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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