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FDA 510(k)

PRIMA, INC. CORRUGATED TUBING

K-Number: K944531 · 1994-12-02

ApplicantPrima, Inc.
Decision Date1994-12-02
Product CodeBZO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRIMA, INC. CORRUGATED TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Prima, Inc.. It received FDA 510(k) clearance on 1994-12-02 under 510(k) number K944531. The device is classified under product code BZO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMA, INC. CORRUGATED TUBING?

PRIMA, INC. CORRUGATED TUBING is a medical device that received FDA 510(k) clearance on 1994-12-02. The listed applicant is Prima, Inc.. The 510(k) number is K944531.

When did PRIMA, INC. CORRUGATED TUBING receive FDA 510(k) clearance?

PRIMA, INC. CORRUGATED TUBING received FDA 510(k) clearance on 1994-12-02, under 510(k) number K944531.

Who is the listed applicant for PRIMA, INC. CORRUGATED TUBING?

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

What is the FDA product code for PRIMA, INC. CORRUGATED TUBING?

The FDA product code for PRIMA, INC. CORRUGATED TUBING is BZO.

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Other records listing Prima, 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.

K952010PRIMA VENTILATOR HOSESK952011PRIMA BREATHING BAGSK952022PRIMA VOLUMN VENTILATORSSK952018PRIMA COAXIAL CIRCUITSK952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSK952012PRIMA CUSTOM ANESTESIA CIRCUIT

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Related Devices (Code: BZO)

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.

K953784UNICOR, INC. CORRUGATED TUBINGUnicor, Inc.K953785UNICOR, INC. VENTILATOR HOSESUnicor, Inc.K952022PRIMA VOLUMN VENTILATORSSPrima, Inc.K952011PRIMA BREATHING BAGSPrima, Inc.K952010PRIMA VENTILATOR HOSESPrima, Inc.K952012PRIMA CUSTOM ANESTESIA CIRCUITPrima, 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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