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FDA 510(k)

TANGO, MODELS, BP1

K-Number: K031711 · 2003-12-18

ApplicantAmerican Bantex Corp.
Decision Date2003-12-18
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TANGO, MODELS, BP1 is the device name listed in this FDA 510(k) record. The listed applicant is American Bantex Corp.. It received FDA 510(k) clearance on 2003-12-18 under 510(k) number K031711. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANGO, MODELS, BP1?

TANGO, MODELS, BP1 is a medical device that received FDA 510(k) clearance on 2003-12-18. The listed applicant is American Bantex Corp.. The 510(k) number is K031711.

When did TANGO, MODELS, BP1 receive FDA 510(k) clearance?

TANGO, MODELS, BP1 received FDA 510(k) clearance on 2003-12-18, under 510(k) number K031711.

Who is the listed applicant for TANGO, MODELS, BP1?

The FDA 510(k) record lists American Bantex Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TANGO, MODELS, BP1?

The FDA product code for TANGO, MODELS, BP1 is ITI.

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Other records listing American Bantex Corp. 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.

K042104AMERICAN BANTEX, MODEL MS 3K041963AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSIK040754AMERICAN BANTEX MS 4 MINI SCOOTERK963218BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SURGICSL GLOVES, STERILE

Related Devices (Code: ITI)

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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Official Source

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

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