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FDA 510(k)

ROEKO CALCIUM HYDROXIDE POINTS

K-Number: K973539 · 1997-10-30

ApplicantRoeko USA, Inc.
Decision Date1997-10-30
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROEKO CALCIUM HYDROXIDE POINTS is the device name listed in this FDA 510(k) record. The listed applicant is Roeko USA, Inc.. It received FDA 510(k) clearance on 1997-10-30 under 510(k) number K973539. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROEKO CALCIUM HYDROXIDE POINTS?

ROEKO CALCIUM HYDROXIDE POINTS is a medical device that received FDA 510(k) clearance on 1997-10-30. The listed applicant is Roeko USA, Inc.. The 510(k) number is K973539.

When did ROEKO CALCIUM HYDROXIDE POINTS receive FDA 510(k) clearance?

ROEKO CALCIUM HYDROXIDE POINTS received FDA 510(k) clearance on 1997-10-30, under 510(k) number K973539.

Who is the listed applicant for ROEKO CALCIUM HYDROXIDE POINTS?

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

What is the FDA product code for ROEKO CALCIUM HYDROXIDE POINTS?

The FDA product code for ROEKO CALCIUM HYDROXIDE POINTS is EJK.

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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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