MOUTH WASH TRAY— 510(k) K770120

Name: FDA 510(k) clearance K770120
Creator: U.S. Food and Drug Administration
Published: 1977-01-28

Substantially Equivalent

Pharmaseal Div., Baxter Healthcare Corp.

FDA 510(k) clearance K770120 for MOUTH WASH TRAY, Substantially Equivalent on 1977-01-28. Applicant: Pharmaseal Div., Baxter Healthcare Corp.. Device class: 1.

Clearance details

Applicant: Pharmaseal Div., Baxter Healthcare Corp.
Product code: Code FMA
Device class: Class 1
Regulation: 21 CFR 880.6230
Advisory panel: General Hospital
Date received: 1977-01-21
Decision date: 1977-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMA

view all

K992995 — AROMATIC AND FLAVORED TONGUE DEPRESSOR1999-12-09
K842461 — TONGUE DEPRESSOR1984-11-30
K830705 — MINI LANCET-BLOOD LANCET1983-04-08
K821177 — BITE STICK1982-05-21

More clearances from Pharmaseal Div., Baxter Healthcare Corp.

view all

K792369 — HYPERALIMENTATION DRESSING TRAY1979-12-10
K792141 — CONTINUOUS FLUSH DEVICE1979-12-05
K792019 — PHADECODE XA INHIBITOR ASSAY1979-11-05
K791773 — VENTILATOR TUBE WITH FILTER1979-10-22
K791156 — AMIPAQUE MYELOGRAM TRAY1979-07-30

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