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FDA 510(k)

FLEXI-THERM FILM

K-Number: K770986 · 1977-09-12

ApplicantE-Z-Em, Inc.
Decision Date1977-09-12
Product CodeKXZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FLEXI-THERM FILM is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1977-09-12 under 510(k) number K770986. The device is classified under product code KXZ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXI-THERM FILM?

FLEXI-THERM FILM is a medical device that received FDA 510(k) clearance on 1977-09-12. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K770986.

When did FLEXI-THERM FILM receive FDA 510(k) clearance?

FLEXI-THERM FILM received FDA 510(k) clearance on 1977-09-12, under 510(k) number K770986.

Who is the listed applicant for FLEXI-THERM FILM?

The FDA 510(k) record lists E-Z-Em, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXI-THERM FILM?

The FDA product code for FLEXI-THERM FILM is KXZ.

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Other records listing E-Z-Em, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071378MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIESK062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730K063029EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900K053008E-Z-EM ENDOSCOPIC CO2 REGULATORK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

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Related Devices (Code: KXZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K851034NOVATHERMMedtech Products, Inc.K843124Q-SCAN THERMOGRAPHY SYSTEMQmax Medical, Inc.K832731BREAST & BODY HEALTH SYSTEM 2000American Thermal Instruments, Inc.K813547THERMASCANBcd Products, Inc.K781916FLEXT-THERME-Z-Em, Inc.K770678ELC-THERMO-SYSTEMCutter Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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