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FDA 510(k)

EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM

K-Number: K964919 · 1997-01-28

ApplicantEmerald Medical, Inc.
Decision Date1997-01-28
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Emerald Medical, Inc.. It received FDA 510(k) clearance on 1997-01-28 under 510(k) number K964919. 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 EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM?

EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-28. The listed applicant is Emerald Medical, Inc.. The 510(k) number is K964919.

When did EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM receive FDA 510(k) clearance?

EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM received FDA 510(k) clearance on 1997-01-28, under 510(k) number K964919.

Who is the listed applicant for EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM?

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

What is the FDA product code for EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM?

The FDA product code for EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM is HRX.

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Other records listing Emerald Medical, Inc. as applicant

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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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