KRONNER MANIPUJECTOR— 510(k) K904473

Substantially Equivalent

Unimar, Inc.

FDA 510(k) clearance K904473 for KRONNER MANIPUJECTOR, Substantially Equivalent on 1990-12-14. Applicant: Unimar, Inc.. Device class: 2.

Clearance details

Applicant: Unimar, Inc.
Product code: Code HES
Device class: Class 2
Regulation: 21 CFR 884.1300
Advisory panel: Obstetrics/Gynecology
Date received: 1990-10-01
Decision date: 1990-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilton, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HES

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K901413 — CORE DISPOSABLE INSUFFLATION TUBING1990-09-24

More clearances from Unimar, Inc.

K932432 — KRONNER REINFORCING STYLETTE1994-04-12
K920803 — HSG TRAY1992-10-19
K910317 — UNI-SEM(TM)1991-05-01
K895659 — HUI MINI-FLEX1989-12-19
K895403 — ASPIRETTE ENDOCERVICAL ASPIRATOR1989-11-29

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