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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Pressure, Gas
510(k) Number K801258
Device Name NEEDLE COUNTER-SURE COUNT/10 COUNT
Applicant
KLEEN TEST PRODUCTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KLEEN TEST PRODUCTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2620
Classification Product Code
BXX  
Date Received05/28/1980
Decision Date 06/04/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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