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FDA 510(k)

COUNT-10 STAIN

K-Number: K823363 · 1982-12-15

ApplicantV-Tech, Inc.
Decision Date1982-12-15
Product CodeLEE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COUNT-10 STAIN is the device name listed in this FDA 510(k) record. The listed applicant is V-Tech, Inc.. It received FDA 510(k) clearance on 1982-12-15 under 510(k) number K823363. The device is classified under product code LEE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COUNT-10 STAIN?

COUNT-10 STAIN is a medical device that received FDA 510(k) clearance on 1982-12-15. The listed applicant is V-Tech, Inc.. The 510(k) number is K823363.

When did COUNT-10 STAIN receive FDA 510(k) clearance?

COUNT-10 STAIN received FDA 510(k) clearance on 1982-12-15, under 510(k) number K823363.

Who is the listed applicant for COUNT-10 STAIN?

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

What is the FDA product code for COUNT-10 STAIN?

The FDA product code for COUNT-10 STAIN is LEE.

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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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