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FDA 510(k)

SURESEAL BANDAGE

K-Number: K922441 · 1993-08-10

ApplicantGainor Medical Europe, Ltd.
Decision Date1993-08-10
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURESEAL BANDAGE is the device name listed in this FDA 510(k) record. The listed applicant is Gainor Medical Europe, Ltd.. It received FDA 510(k) clearance on 1993-08-10 under 510(k) number K922441. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURESEAL BANDAGE?

SURESEAL BANDAGE is a medical device that received FDA 510(k) clearance on 1993-08-10. The listed applicant is Gainor Medical Europe, Ltd.. The 510(k) number is K922441.

When did SURESEAL BANDAGE receive FDA 510(k) clearance?

SURESEAL BANDAGE received FDA 510(k) clearance on 1993-08-10, under 510(k) number K922441.

Who is the listed applicant for SURESEAL BANDAGE?

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

What is the FDA product code for SURESEAL BANDAGE?

The FDA product code for SURESEAL BANDAGE is KGX.

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Other records listing Gainor Medical Europe, Ltd. 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.

K926448I.V. ADMINISTRATION SETK931828CARELET SAFETY LANCETK931827CLEANLET, CLEANLET XL & KIDSK913333I.V. PRIMING SETK902422NEEDLE, ASPIRATION & INJECTION, DISPOSABLEK902420CATHETER, NASAL, OXYGEN

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Related Devices (Code: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, Inc.

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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