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FDA 510(k)

BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME

K-Number: K990376 · 1999-05-03

Decision Date1999-05-03
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME is the device name listed in this FDA 510(k) record. The listed applicant is Ballard Medical Products. It received FDA 510(k) clearance on 1999-05-03 under 510(k) number K990376. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME?

BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME is a medical device that received FDA 510(k) clearance on 1999-05-03. The listed applicant is Ballard Medical Products. The 510(k) number is K990376.

When did BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME receive FDA 510(k) clearance?

BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME received FDA 510(k) clearance on 1999-05-03, under 510(k) number K990376.

Who is the listed applicant for BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME?

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

What is the FDA product code for BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME?

The FDA product code for BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME is KNS.

Related Clinical Trials

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.

Other records listing Ballard Medical Products 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.

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Related Devices (Code: KNS)

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.

Official Source

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

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