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FDA 510(k)

SYVEK PATCH

K-Number: K972914 · 1997-12-22

ApplicantMarine Polymer Technologies, Inc.
Decision Date1997-12-22
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYVEK PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Marine Polymer Technologies, Inc.. It received FDA 510(k) clearance on 1997-12-22 under 510(k) number K972914. 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 SYVEK PATCH?

SYVEK PATCH is a medical device that received FDA 510(k) clearance on 1997-12-22. The listed applicant is Marine Polymer Technologies, Inc.. The 510(k) number is K972914.

When did SYVEK PATCH receive FDA 510(k) clearance?

SYVEK PATCH received FDA 510(k) clearance on 1997-12-22, under 510(k) number K972914.

Who is the listed applicant for SYVEK PATCH?

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

What is the FDA product code for SYVEK PATCH?

The FDA product code for SYVEK PATCH is KGX.

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Other records listing Marine Polymer Technologies, 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.

K160695Talymed SuspensionK111524MP 719K082703MRDH BANDAGEK070557MP 719K053300SYVEKEXCELK002550RDH BANDAGE

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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.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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