DYMAX ENDOVAGINAL BIOPSY GUIDE— 510(k) K894415

Substantially Equivalent

Dymax Corp

FDA 510(k) clearance K894415 for DYMAX ENDOVAGINAL BIOPSY GUIDE, Substantially Equivalent on 1989-10-25. Applicant: Dymax Corp. Device class: 2.

Clearance details

Applicant: Dymax Corp
Product code: Code HGL
Device class: Class 2
Regulation: 21 CFR 884.2960
Advisory panel: Obstetrics/Gynecology
Date received: 1989-07-17
Decision date: 1989-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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K900966 — EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE1990-09-12

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K903158 — SITERITE NEEDLE GUIDE1990-09-27
K862127 — DYMAX PERSONAL SCANNER1986-12-11

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