FLEXI-THERM FILM— 510(k) K770986

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K770986 for FLEXI-THERM FILM, Substantially Equivalent on 1977-09-12. Applicant: E-Z-Em, Inc.. Device class: 3.

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code KXZ
Device class: Class 3
Regulation: 21 CFR 884.2982
Advisory panel: Obstetrics/Gynecology
Date received: 1977-05-31
Decision date: 1977-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXZ

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K832731 — BREAST & BODY HEALTH SYSTEM 20001984-01-30
K813547 — THERMASCAN1982-03-12
K781916 — FLEXT-THERM1979-02-02

More clearances from E-Z-Em, Inc.

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K063029 — EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/99002006-11-02
K053008 — E-Z-EM ENDOSCOPIC CO2 REGULATOR2005-12-27
K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725)2004-07-16

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