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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 K993017
Device Name PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE
Applicant
Shinchang Medical Co., Ltd.
3762 S. 150 E.
Salt Lake City,  UT  84115
Applicant Contact JAN J FRANK
Correspondent
Shinchang Medical Co., Ltd.
3762 S. 150 E.
Salt Lake City,  UT  84115
Correspondent Contact JAN J FRANK
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/08/1999
Decision Date 02/25/2000
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
Recalls CDRH Recalls
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