FDA 510(k)

SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER

K-Number: K821394 · 1982-06-03

Decision Date1982-06-03

Product CodeMMK

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER 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 1982-06-03 under 510(k) number K821394. 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 SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER?

SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER is a medical device that received FDA 510(k) clearance on 1982-06-03. The listed applicant is Kleen Test Products. The 510(k) number is K821394.

When did SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER receive FDA 510(k) clearance?

SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER received FDA 510(k) clearance on 1982-06-03, under 510(k) number K821394.

Who is the listed applicant for SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER?

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 SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER?

The FDA product code for SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER is MMK.

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Other records listing Kleen Test Products as applicant

K890039KLEEN TEST BASIN SET K890539SURE COUNT LIGHT HANDLE COVER K890098KLEEN TEST O.R. KIT K853622SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030 K853454SURE COUNT 5 & 10 SPONGE COUNTER K853315CAUTERY TIP CLEANING PAD

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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.