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FDA 510(k)

RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D

K-Number: K071173 · 2007-05-25

ApplicantOssur Americans (Formerly the Jerome Group)
Decision Date2007-05-25
Product CodeHAX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D is the device name listed in this FDA 510(k) record. The listed applicant is Ossur Americans (Formerly the Jerome Group). It received FDA 510(k) clearance on 2007-05-25 under 510(k) number K071173. The device is classified under product code HAX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D?

RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D is a medical device that received FDA 510(k) clearance on 2007-05-25. The listed applicant is Ossur Americans (Formerly the Jerome Group). The 510(k) number is K071173.

When did RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D receive FDA 510(k) clearance?

RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D received FDA 510(k) clearance on 2007-05-25, under 510(k) number K071173.

Who is the listed applicant for RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D?

The FDA 510(k) record lists Ossur Americans (Formerly the Jerome Group) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D?

The FDA product code for RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D is HAX.

Related Clinical Trials

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Related Devices (Code: HAX)

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.

K090733PMT HALO SYSTEMPmt Corp.K051918RESOLVE OPEN BACK HALO RINGSJerome MedicalK023959JEROME GLASS RINGThe Jerome Group, Inc.K003662SPINE WORKS COLLARSpine WorksK980689FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEMFriddle'S Orthopedic Appliances, Inc.K930021J TONGSJerome Medical

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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