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FDA 510(k)

DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006

K-Number: K052309 · 2005-09-27

ApplicantSaehan Corp.
Decision Date2005-09-27
Product CodeLBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 is the device name listed in this FDA 510(k) record. The listed applicant is Saehan Corp.. It received FDA 510(k) clearance on 2005-09-27 under 510(k) number K052309. The device is classified under product code LBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006?

DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 is a medical device that received FDA 510(k) clearance on 2005-09-27. The listed applicant is Saehan Corp.. The 510(k) number is K052309.

When did DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 receive FDA 510(k) clearance?

DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 received FDA 510(k) clearance on 2005-09-27, under 510(k) number K052309.

Who is the listed applicant for DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006?

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

What is the FDA product code for DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006?

The FDA product code for DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 is LBB.

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Related Devices (Code: LBB)

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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