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FDA 510(k)

SURE-COUNT DISPOSABLE NEEDLE COUNTER

K-Number: K822735 · 1983-03-09

ApplicantGeneva Laboratories, Inc.
Decision Date1983-03-09
Product CodeMMK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURE-COUNT DISPOSABLE NEEDLE COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Geneva Laboratories, Inc.. It received FDA 510(k) clearance on 1983-03-09 under 510(k) number K822735. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURE-COUNT DISPOSABLE NEEDLE COUNTER?

SURE-COUNT DISPOSABLE NEEDLE COUNTER is a medical device that received FDA 510(k) clearance on 1983-03-09. The listed applicant is Geneva Laboratories, Inc.. The 510(k) number is K822735.

When did SURE-COUNT DISPOSABLE NEEDLE COUNTER receive FDA 510(k) clearance?

SURE-COUNT DISPOSABLE NEEDLE COUNTER received FDA 510(k) clearance on 1983-03-09, under 510(k) number K822735.

Who is the listed applicant for SURE-COUNT DISPOSABLE NEEDLE COUNTER?

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

What is the FDA product code for SURE-COUNT DISPOSABLE NEEDLE COUNTER?

The FDA product code for SURE-COUNT DISPOSABLE NEEDLE COUNTER is MMK.

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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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