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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K880350
Device Name YUE/FA DISPOSABLE SYRINGE
Applicant
Honway International Co.
1020 Stockton St. #308
San Francisco,  CA  94108
Applicant Contact KEN CHIN
Correspondent
Honway International Co.
1020 Stockton St. #308
San Francisco,  CA  94108
Correspondent Contact KEN CHIN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/26/1988
Decision Date 02/16/1988
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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