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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Acupuncture, Single Use
510(k) Number K000740
Device Name ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S
Applicant
Asahi Iryoki Co., Ltd.
10 New King St.
Suite 106
White Plains,  NY  10604
Applicant Contact MIKE PAWLUK
Correspondent
Asahi Iryoki Co., Ltd.
10 New King St.
Suite 106
White Plains,  NY  10604
Correspondent Contact MIKE PAWLUK
Regulation Number880.5580
Classification Product Code
MQX  
Date Received03/07/2000
Decision Date 04/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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