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FDA 510(k)

MED-SURG SUTURE WASHER

K-Number: K950250 · 1995-05-17

ApplicantMedical Surgical, Inc.
Decision Date1995-05-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

MED-SURG SUTURE WASHER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Surgical, Inc.. It received FDA 510(k) clearance on 1995-05-17 under 510(k) number K950250. 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 for Some Indications.

Frequently Asked Questions

What is the MED-SURG SUTURE WASHER?

MED-SURG SUTURE WASHER is a medical device that received FDA 510(k) clearance on 1995-05-17. The listed applicant is Medical Surgical, Inc.. The 510(k) number is K950250.

When did MED-SURG SUTURE WASHER receive FDA 510(k) clearance?

MED-SURG SUTURE WASHER received FDA 510(k) clearance on 1995-05-17, under 510(k) number K950250.

Who is the listed applicant for MED-SURG SUTURE WASHER?

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

What is the FDA product code for MED-SURG SUTURE WASHER?

The FDA product code for MED-SURG SUTURE WASHER is HWC. This falls under the Cardiovascular category.

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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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