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FDA 510(k)

NEEDLE COUNTER-SURE COUNT/100 COUNT

K-Number: K801259 · 1980-06-09

ApplicantKleen Test Products
Decision Date1980-06-09
Product CodeMMK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEEDLE COUNTER-SURE COUNT/100 COUNT is the device name listed in this FDA 510(k) record. The listed applicant is Kleen Test Products. It received FDA 510(k) clearance on 1980-06-09 under 510(k) number K801259. 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 NEEDLE COUNTER-SURE COUNT/100 COUNT?

NEEDLE COUNTER-SURE COUNT/100 COUNT is a medical device that received FDA 510(k) clearance on 1980-06-09. The listed applicant is Kleen Test Products. The 510(k) number is K801259.

When did NEEDLE COUNTER-SURE COUNT/100 COUNT receive FDA 510(k) clearance?

NEEDLE COUNTER-SURE COUNT/100 COUNT received FDA 510(k) clearance on 1980-06-09, under 510(k) number K801259.

Who is the listed applicant for NEEDLE COUNTER-SURE COUNT/100 COUNT?

The FDA 510(k) record lists Kleen Test Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEEDLE COUNTER-SURE COUNT/100 COUNT?

The FDA product code for NEEDLE COUNTER-SURE COUNT/100 COUNT is MMK.

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Other records listing Kleen Test Products as applicant

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.

K890039KLEEN TEST BASIN SETK890539SURE COUNT LIGHT HANDLE COVERK890098KLEEN TEST O.R. KITK853622SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030K853454SURE COUNT 5 & 10 SPONGE COUNTERK853315CAUTERY TIP CLEANING PAD

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Related Devices (Code: MMK)

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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