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FDA 510(k)

FLUOROFILM(R)

K-Number: K933800 · 1994-06-24

ApplicantAmerican Custom Medical, Inc.
Decision Date1994-06-24
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FLUOROFILM(R) is the device name listed in this FDA 510(k) record. The listed applicant is American Custom Medical, Inc.. It received FDA 510(k) clearance on 1994-06-24 under 510(k) number K933800. The device is classified under product code EMX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUOROFILM(R)?

FLUOROFILM(R) is a medical device that received FDA 510(k) clearance on 1994-06-24. The listed applicant is American Custom Medical, Inc.. The 510(k) number is K933800.

When did FLUOROFILM(R) receive FDA 510(k) clearance?

FLUOROFILM(R) received FDA 510(k) clearance on 1994-06-24, under 510(k) number K933800.

Who is the listed applicant for FLUOROFILM(R)?

The FDA 510(k) record lists American Custom Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLUOROFILM(R)?

The FDA product code for FLUOROFILM(R) is EMX.

Related Clinical Trials

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.

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Other records listing American Custom Medical, 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.

K965205TEFGEN - LSK964656TEFGEN GUIDED TISSUE MEMBRANEK944413ACM PTFE SURGICAL MESHK935137TEFGEN-FD

Related Devices (Code: EMX)

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.

K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLCK041446NASALCEASELes Laboratorires Brothier, S.A.K000108RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100Bhk HoldingK993362HYLASINEBiomatrix, Inc.K983276HYDROFERA BACTERISTATIC NASAL DRESSINGHydrofera, LLCK982731MEROGEL NASAL DRESSING AND SINUS STENTXomed, 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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