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FDA 510(k)

BOAT NOSE OBTURATOR

K-Number: K954458 · 1995-10-23

ApplicantPhx Technologies Corp.
Decision Date1995-10-23
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BOAT NOSE OBTURATOR is the device name listed in this FDA 510(k) record. The listed applicant is Phx Technologies Corp.. It received FDA 510(k) clearance on 1995-10-23 under 510(k) number K954458. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOAT NOSE OBTURATOR?

BOAT NOSE OBTURATOR is a medical device that received FDA 510(k) clearance on 1995-10-23. The listed applicant is Phx Technologies Corp.. The 510(k) number is K954458.

When did BOAT NOSE OBTURATOR receive FDA 510(k) clearance?

BOAT NOSE OBTURATOR received FDA 510(k) clearance on 1995-10-23, under 510(k) number K954458.

Who is the listed applicant for BOAT NOSE OBTURATOR?

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

What is the FDA product code for BOAT NOSE OBTURATOR?

The FDA product code for BOAT NOSE OBTURATOR is HRX.

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Other records listing Phx Technologies Corp. as applicant

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Related Devices (Code: HRX)

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

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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