CO-1000 COLPOSCOPE, MULTIPLE— 510(k) K061306

Substantially Equivalent

Gynex Corp.

FDA 510(k) clearance K061306 for CO-1000 COLPOSCOPE, MULTIPLE, Substantially Equivalent on 2006-08-07. Applicant: Gynex Corp.. Device class: 2.

Clearance details

Applicant: Gynex Corp.
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 2006-05-10
Decision date: 2006-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Gynex Corp.

K982739 — GYNEX ELECTRODES1999-03-12
K980238 — GYNEX EXTENDED REACH NEEDLE1998-08-21
K980237 — GYNEX ENDOSPECULUM1998-04-08
K980247 — GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM1998-03-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.