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FDA 510(k)

PATCHASSIST LARGE

K-Number: K103269 · 2010-11-23

ApplicantPolytouch Medical, Ltd.
Decision Date2010-11-23
Product CodeORQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PATCHASSIST LARGE is the device name listed in this FDA 510(k) record. The listed applicant is Polytouch Medical, Ltd.. It received FDA 510(k) clearance on 2010-11-23 under 510(k) number K103269. The device is classified under product code ORQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATCHASSIST LARGE?

PATCHASSIST LARGE is a medical device that received FDA 510(k) clearance on 2010-11-23. The listed applicant is Polytouch Medical, Ltd.. The 510(k) number is K103269.

When did PATCHASSIST LARGE receive FDA 510(k) clearance?

PATCHASSIST LARGE received FDA 510(k) clearance on 2010-11-23, under 510(k) number K103269.

Who is the listed applicant for PATCHASSIST LARGE?

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

What is the FDA product code for PATCHASSIST LARGE?

The FDA product code for PATCHASSIST LARGE is ORQ.

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 Polytouch Medical, 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.

K101218PATCHASSIST

Related Devices (Code: ORQ)

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.

K250395BioBrace ® RC Delivery SystemConmed CorporationK130782ACCUMESH DEPLOYMENT SYSTEMCovidien, LLCK123066ACCUMESH DEPLOYMENT SYSTEMCovidien, LLCK121139ACCUMESH DEPLOYMENT SYSTEMCovidien, LLCK101218PATCHASSISTPolytouch Medical, Ltd.

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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