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FDA 510(k)

OGDEN ANCHOR ADDITIONAL APPLICATIONS

K-Number: K935065 · 1995-01-30

ApplicantAmerican Medical Electronics, Inc.
Decision Date1995-01-30
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OGDEN ANCHOR ADDITIONAL APPLICATIONS is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Electronics, Inc.. It received FDA 510(k) clearance on 1995-01-30 under 510(k) number K935065. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OGDEN ANCHOR ADDITIONAL APPLICATIONS?

OGDEN ANCHOR ADDITIONAL APPLICATIONS is a medical device that received FDA 510(k) clearance on 1995-01-30. The listed applicant is American Medical Electronics, Inc.. The 510(k) number is K935065.

When did OGDEN ANCHOR ADDITIONAL APPLICATIONS receive FDA 510(k) clearance?

OGDEN ANCHOR ADDITIONAL APPLICATIONS received FDA 510(k) clearance on 1995-01-30, under 510(k) number K935065.

Who is the listed applicant for OGDEN ANCHOR ADDITIONAL APPLICATIONS?

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

What is the FDA product code for OGDEN ANCHOR ADDITIONAL APPLICATIONS?

The FDA product code for OGDEN ANCHOR ADDITIONAL APPLICATIONS is JDR.

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Other records listing American Medical Electronics, 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.

K951232EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MMK952348OGDEN ANCHORK950875OGDEN ANCHORK951493OGDEN ANCHORK951545OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONSK941029OGDEN ANCHOR-SMALL (TENTATIVE)

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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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