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FDA 510(k)

J TONGS

K-Number: K930021 · 1995-12-06

ApplicantJerome Medical
Decision Date1995-12-06
Product CodeHAX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

J TONGS is the device name listed in this FDA 510(k) record. The listed applicant is Jerome Medical. It received FDA 510(k) clearance on 1995-12-06 under 510(k) number K930021. 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 J TONGS?

J TONGS is a medical device that received FDA 510(k) clearance on 1995-12-06. The listed applicant is Jerome Medical. The 510(k) number is K930021.

When did J TONGS receive FDA 510(k) clearance?

J TONGS received FDA 510(k) clearance on 1995-12-06, under 510(k) number K930021.

Who is the listed applicant for J TONGS?

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

What is the FDA product code for J TONGS?

The FDA product code for J TONGS is HAX.

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Other records listing Jerome Medical 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.

K051918RESOLVE OPEN BACK HALO RINGSK930153SYSTEM III HALO RINGK882877JMS CERVICAL TRACTION DEVICE/HALO DEVICEK870053TORQUEDRIVER WRENCHK864969JMS HALO APPLICATION TRAYK844490TRACTION ACCESSORIES

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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.K071173RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100DOssur Americans (Formerly the Jerome Group)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.

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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