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FDA 510(k)

PrimeLOC Attachment System

K-Number: K220612 · 2022-06-06

ApplicantInnovative Product Brands, Inc.
Decision Date2022-06-06
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PrimeLOC Attachment System is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Product Brands, Inc.. It received FDA 510(k) clearance on 2022-06-06 under 510(k) number K220612. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PrimeLOC Attachment System?

PrimeLOC Attachment System is a medical device that received FDA 510(k) clearance on 2022-06-06. The listed applicant is Innovative Product Brands, Inc.. The 510(k) number is K220612.

When did PrimeLOC Attachment System receive FDA 510(k) clearance?

PrimeLOC Attachment System received FDA 510(k) clearance on 2022-06-06, under 510(k) number K220612.

Who is the listed applicant for PrimeLOC Attachment System?

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

What is the FDA product code for PrimeLOC Attachment System?

The FDA product code for PrimeLOC Attachment System is NHA.

Other records listing Innovative Product Brands, 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.

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Related Devices (Code: NHA)

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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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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