DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN— 510(k) K800956

Name: FDA 510(k) clearance K800956
Creator: U.S. Food and Drug Administration
Published: 1980-10-03

Substantially Equivalent

The Healthcare Group Laboratories, Inc.

FDA 510(k) clearance K800956 for DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN, Substantially Equivalent on 1980-10-03. Applicant: The Healthcare Group Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: The Healthcare Group Laboratories, Inc.
Product code: Code HED
Device class: Class 1
Regulation: 21 CFR 884.5900
Advisory panel: Obstetrics/Gynecology
Date received: 1980-04-23
Decision date: 1980-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HED

view all

K080200 — WATER WORKS DOUCHING DEVICE2008-07-10
K030056 — WORRY-REMOVER IRRIGATOR2003-04-22
K000736 — LA JOIE2000-08-08
K902830 — PERI-BOTTLE1990-08-06
K881216 — GENT-L-KARE VAGINAL IRRIGATION SET1988-06-07

More clearances from The Healthcare Group Laboratories, Inc.

view all

K850035 — EMPTY SOLUTION TRANSFER CONTAINER1985-06-07
K842170 — EMPTY SOLUTION TRANSFER CONTAINER1984-10-19
K842091 — DISPOS. ACU-CUT SOFT TISSUE BIOPSY1984-07-23
K840742 — RIGHT ATRIAL CATHETER1984-07-13
K830299 — SOLUTION TRANSFER CONTAINER1983-02-19

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