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FDA 510(k)

ACUMED SUTURE WASHER

K-Number: K965028 · 1997-03-17

ApplicantAcu Med, Inc.
Decision Date1997-03-17
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUMED SUTURE WASHER is the device name listed in this FDA 510(k) record. The listed applicant is Acu Med, Inc.. It received FDA 510(k) clearance on 1997-03-17 under 510(k) number K965028. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUMED SUTURE WASHER?

ACUMED SUTURE WASHER is a medical device that received FDA 510(k) clearance on 1997-03-17. The listed applicant is Acu Med, Inc.. The 510(k) number is K965028.

When did ACUMED SUTURE WASHER receive FDA 510(k) clearance?

ACUMED SUTURE WASHER received FDA 510(k) clearance on 1997-03-17, under 510(k) number K965028.

Who is the listed applicant for ACUMED SUTURE WASHER?

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

What is the FDA product code for ACUMED SUTURE WASHER?

The FDA product code for ACUMED SUTURE WASHER is HTN.

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Other records listing Acu Med, 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.

K021321WRIST FUSION PLATEK013616POLARUS CAP SCREWK012655CONGRUENT BONE PLATE SYSTEMK992525ACUMED MODULAR SHOULDER SYSTEMK993657ACUMED SUTURE ANCHORK980103ACUMED SUTURE ANCHOR

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Related Devices (Code: HTN)

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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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