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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K970370
Device Name TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE
Applicant
TSK LABORATORY, JAPAN
2-1-5, HIRAYANAGI-CHO
TOCHIGI-SHI, TOCHIGI-KEN,  JP
Applicant Contact NORMAN S JOHNSON
Correspondent
TSK LABORATORY, JAPAN
2-1-5, HIRAYANAGI-CHO
TOCHIGI-SHI, TOCHIGI-KEN,  JP
Correspondent Contact NORMAN S JOHNSON
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/31/1997
Decision Date 04/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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