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FDA 510(k)

APDYNE PHENOL APPLICATOR KIT

K-Number: K894369 · 1989-10-12

ApplicantApdyne Medical Co.
Decision Date1989-10-12
Product CodeKCJ
Advisory CommitteeEN
DecisionUnknown

Device Summary

APDYNE PHENOL APPLICATOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Apdyne Medical Co.. It received FDA 510(k) clearance on 1989-10-12 under 510(k) number K894369. The device is classified under product code KCJ. It was reviewed by the EN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the APDYNE PHENOL APPLICATOR KIT?

APDYNE PHENOL APPLICATOR KIT is a medical device that received FDA 510(k) clearance on 1989-10-12. The listed applicant is Apdyne Medical Co.. The 510(k) number is K894369.

When did APDYNE PHENOL APPLICATOR KIT receive FDA 510(k) clearance?

APDYNE PHENOL APPLICATOR KIT received FDA 510(k) clearance on 1989-10-12, under 510(k) number K894369.

Who is the listed applicant for APDYNE PHENOL APPLICATOR KIT?

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

What is the FDA product code for APDYNE PHENOL APPLICATOR KIT?

The FDA product code for APDYNE PHENOL APPLICATOR KIT is KCJ.

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.

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Other records listing Apdyne Medical Co. 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.

K911080HYGIENA-TRACH

Related Devices (Code: KCJ)

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.

K923679ENDOPATH TISSUE RETAINING COMPONENTEthicon Endo-Surgery, Inc.K921053LAPAROMED LIGATING LOOPLaparomed Corp.K832667LUCAE'S EAR & NASAL APPLICATORSKells Medical, Inc.

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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