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FDA 510(k)

K-APATITE 20-40 MESH K-APATITE 40-60

K-Number: K843557 · 1984-11-30

ApplicantKatecho, Inc.
Decision Date1984-11-30
Product CodeELE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

K-APATITE 20-40 MESH K-APATITE 40-60 is the device name listed in this FDA 510(k) record. The listed applicant is Katecho, Inc.. It received FDA 510(k) clearance on 1984-11-30 under 510(k) number K843557. The device is classified under product code ELE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-APATITE 20-40 MESH K-APATITE 40-60?

K-APATITE 20-40 MESH K-APATITE 40-60 is a medical device that received FDA 510(k) clearance on 1984-11-30. The listed applicant is Katecho, Inc.. The 510(k) number is K843557.

When did K-APATITE 20-40 MESH K-APATITE 40-60 receive FDA 510(k) clearance?

K-APATITE 20-40 MESH K-APATITE 40-60 received FDA 510(k) clearance on 1984-11-30, under 510(k) number K843557.

Who is the listed applicant for K-APATITE 20-40 MESH K-APATITE 40-60?

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

What is the FDA product code for K-APATITE 20-40 MESH K-APATITE 40-60?

The FDA product code for K-APATITE 20-40 MESH K-APATITE 40-60 is ELE.

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Other records listing Katecho, 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.

K012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85K010543KM-30 TENS ELECTRODEK003228K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70AK002806K-DEFIB/PACE, MODEL KDP-60AK000870KM-10 TENS ELECTRODEK993745K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80

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Related Devices (Code: ELE)

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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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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