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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 K915780
Device Name RACK AND SYRINGES
Applicant
Normeca Corp.
Kjennvn. 67
1470 Lorenskog
Skaarer,  NO N1473
Applicant Contact JAN KARLSEN
Correspondent
Normeca Corp.
Kjennvn. 67
1470 Lorenskog
Skaarer,  NO N1473
Correspondent Contact JAN KARLSEN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/24/1991
Decision Date 01/27/1993
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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