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FDA 510(k)

MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS

K-Number: K881478 · 1988-09-14

ApplicantKeymed (Medical & Industrial Equipment), Ltd.
Decision Date1988-09-14
Product CodeKNQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS is the device name listed in this FDA 510(k) record. The listed applicant is Keymed (Medical & Industrial Equipment), Ltd.. It received FDA 510(k) clearance on 1988-09-14 under 510(k) number K881478. The device is classified under product code KNQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS?

MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS is a medical device that received FDA 510(k) clearance on 1988-09-14. The listed applicant is Keymed (Medical & Industrial Equipment), Ltd.. The 510(k) number is K881478.

When did MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS receive FDA 510(k) clearance?

MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS received FDA 510(k) clearance on 1988-09-14, under 510(k) number K881478.

Who is the listed applicant for MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS?

The FDA 510(k) record lists Keymed (Medical & Industrial Equipment), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS?

The FDA product code for MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS is KNQ.

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Other records listing Keymed (Medical & Industrial Equipment), Ltd. 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.

K193250Irrigation Tubing with CO2 or AirK100899OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2K011725OLYMPUS SUCTION PUMP, MODEL KV-5K000948OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1K962528OLYMPUS MOBILE CHAIR/COUCHK930852OLYMPUS SUCTION PUMP MODEL KV-4

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Related Devices (Code: KNQ)

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.

K122924CRE FIXED WIRE BALLON DILATION CATHETERBoston Scientific CorpK093236ETHICON ENDO-SURGERYOPTICAL DILATOREthicon Endo-Surgery, Inc.K090183HERCULES 3 STAGE WIRE GUIDED DILATION BALLOONCook EndoscopyK082995SMART DILATORSafestitch MedicalK061937COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOONCook EndoscopyK061787MAXFORCE TTS SINGLE-USE BALLOON DILATORBoston Scientific Corp

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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