FDA 510(k)

FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C

K-Number: K071353 · 2007-12-14

ApplicantShanghai Foshion Medical Instruments Co., Ltd.

Decision Date2007-12-14

Product CodeKLC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Foshion Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2007-12-14 under 510(k) number K071353. The device is classified under product code KLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C?

FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C is a medical device that received FDA 510(k) clearance on 2007-12-14. The listed applicant is Shanghai Foshion Medical Instruments Co., Ltd.. The 510(k) number is K071353.

When did FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C receive FDA 510(k) clearance?

FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C received FDA 510(k) clearance on 2007-12-14, under 510(k) number K071353.

Who is the listed applicant for FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C?

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

What is the FDA product code for FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C?

The FDA product code for FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C is KLC.

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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.