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FDA 510(k)

SERAGARD INJECTION PATCH

K-Number: K001240 · 2000-06-21

ApplicantPlatinum Services, Inc.
Decision Date2000-06-21
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SERAGARD INJECTION PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Platinum Services, Inc.. It received FDA 510(k) clearance on 2000-06-21 under 510(k) number K001240. 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 SERAGARD INJECTION PATCH?

SERAGARD INJECTION PATCH is a medical device that received FDA 510(k) clearance on 2000-06-21. The listed applicant is Platinum Services, Inc.. The 510(k) number is K001240.

When did SERAGARD INJECTION PATCH receive FDA 510(k) clearance?

SERAGARD INJECTION PATCH received FDA 510(k) clearance on 2000-06-21, under 510(k) number K001240.

Who is the listed applicant for SERAGARD INJECTION PATCH?

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

What is the FDA product code for SERAGARD INJECTION PATCH?

The FDA product code for SERAGARD INJECTION PATCH is KGX.

Related Clinical Trials

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.

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Other records listing Platinum Services, 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.

K001175SERAGARD VASCULAR ACCESS PATCH

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.

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.K944587DERMIVIEW HYPOALLERGENIC CLEAR TAPEJohnson & Johnson Medical, 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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