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FDA 510(k)

EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM

K-Number: K951232 · 1995-08-25

ApplicantAmerican Medical Electronics, Inc.
Decision Date1995-08-25
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM 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 1995-08-25 under 510(k) number K951232. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM?

EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM is a medical device that received FDA 510(k) clearance on 1995-08-25. The listed applicant is American Medical Electronics, Inc.. The 510(k) number is K951232.

When did EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM receive FDA 510(k) clearance?

EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM received FDA 510(k) clearance on 1995-08-25, under 510(k) number K951232.

Who is the listed applicant for EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM?

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 EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM?

The FDA product code for EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM is HWC. This falls under the Cardiovascular category.

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Other records listing American Medical Electronics, Inc. as applicant

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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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