DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006— 510(k) K052309

Name: FDA 510(k) clearance K052309
Creator: U.S. Food and Drug Administration
Published: 2005-09-27

Substantially Equivalent

Saehan Corp.

FDA 510(k) clearance K052309 for DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006, Substantially Equivalent on 2005-09-27. Applicant: Saehan Corp.. Device class: 2.

Clearance details

Applicant: Saehan Corp.
Product code: Code LBB
Device class: Class 2
Regulation: 21 CFR 888.1240
Advisory panel: Orthopedic
Date received: 2005-08-24
Decision date: 2005-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flintville, TN, US

Download summary PDF View on FDA.gov ↗

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