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FDA 510(k)

SCANLAN SUTURE BOOTS

K-Number: K810480 · 1981-03-13

ApplicantScanlan Intl., Inc.
Decision Date1981-03-13
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SCANLAN SUTURE BOOTS is the device name listed in this FDA 510(k) record. The listed applicant is Scanlan Intl., Inc.. It received FDA 510(k) clearance on 1981-03-13 under 510(k) number K810480. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCANLAN SUTURE BOOTS?

SCANLAN SUTURE BOOTS is a medical device that received FDA 510(k) clearance on 1981-03-13. The listed applicant is Scanlan Intl., Inc.. The 510(k) number is K810480.

When did SCANLAN SUTURE BOOTS receive FDA 510(k) clearance?

SCANLAN SUTURE BOOTS received FDA 510(k) clearance on 1981-03-13, under 510(k) number K810480.

Who is the listed applicant for SCANLAN SUTURE BOOTS?

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

What is the FDA product code for SCANLAN SUTURE BOOTS?

The FDA product code for SCANLAN SUTURE BOOTS is KOC.

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Other records listing Scanlan Intl., Inc. as applicant

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Related Devices (Code: KOC)

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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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