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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 K011669
Device Name BW ACUPUNCTURE NEEDLES
Applicant
H F Intl. Co.
865 S. Figueroa St.
Suite 2308
Los Angeles,  CA  90017
Applicant Contact JOHN N POLITIS
Correspondent
H F Intl. Co.
865 S. Figueroa St.
Suite 2308
Los Angeles,  CA  90017
Correspondent Contact JOHN N POLITIS
Regulation Number880.5580
Classification Product Code
MQX  
Date Received05/30/2001
Decision Date 07/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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