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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 K962809
Device Name SEIRIN ACUPUNCTURE NEEDLES
Applicant
Seirin-America, Inc.
230 Libbey Pkwy.
Weymouth,  MA  02189
Applicant Contact THOMAS RIIHIMAKI
Correspondent
Seirin-America, Inc.
230 Libbey Pkwy.
Weymouth,  MA  02189
Correspondent Contact THOMAS RIIHIMAKI
Regulation Number880.5580
Classification Product Code
MQX  
Date Received07/18/1996
Decision Date 08/16/1996
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
Predetermined Change
Control Plan Authorized		 No
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