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FDA 510(k)

NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES

K-Number: K073576 · 2008-02-22

ApplicantHarod Enterprises, Inc.
Decision Date2008-02-22
Product CodeHBA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES is the device name listed in this FDA 510(k) record. The listed applicant is Harod Enterprises, Inc.. It received FDA 510(k) clearance on 2008-02-22 under 510(k) number K073576. The device is classified under product code HBA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES?

NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES is a medical device that received FDA 510(k) clearance on 2008-02-22. The listed applicant is Harod Enterprises, Inc.. The 510(k) number is K073576.

When did NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES receive FDA 510(k) clearance?

NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES received FDA 510(k) clearance on 2008-02-22, under 510(k) number K073576.

Who is the listed applicant for NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES?

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

What is the FDA product code for NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES?

The FDA product code for NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES is HBA.

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Related Devices (Code: HBA)

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.

K193346Codman Surgical Patties & StripsIntegra LifeSciences CorporationK112598AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)American Surgical Company, LLCK121822DELICOTAmerican Surgical Company, LLCK062406AESCULAP NEURO PATTIESAesculap, Inc.K031008AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)AesculapK020736TRAATEK COTTONOID PATTIESTraatek, 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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