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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 K990328
FOIA Releasable 510(k) K990328
Device Name DBC, DONG BANG ACUPUNCTURE NEEDLES
Applicant
Morning Star, Dong Bang Acupuncture U.S.A., Inc.
1429 Lyndon St.
South Pasadena,  CA  91030
Applicant Contact AE-HOE KWON
Correspondent
Morning Star, Dong Bang Acupuncture U.S.A., Inc.
1429 Lyndon St.
South Pasadena,  CA  91030
Correspondent Contact AE-HOE KWON
Regulation Number880.5580
Classification Product Code
MQX  
Date Received02/02/1999
Decision Date 05/04/1999
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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