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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 K002569
Device Name GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES
Applicant
Malgam Ent., Inc.
2 Clarence Pl., #12
San Francisco,  CA  94107 -0509
Applicant Contact MICHAEL L GAMBLE
Correspondent
Malgam Ent., Inc.
2 Clarence Pl., #12
San Francisco,  CA  94107 -0509
Correspondent Contact MICHAEL L GAMBLE
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received08/18/2000
Decision Date 12/12/2000
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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