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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 K851523
Device Name DISPOSABLE PLASTIC SYRINGES
Applicant
Transcoject GmbH & Co. KG
Rugenstrasse 8
Neumuenster,  DE 24539
Applicant Contact O KOHLER
Correspondent
Transcoject GmbH & Co. KG
Rugenstrasse 8
Neumuenster,  DE 24539
Correspondent Contact O KOHLER
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/16/1985
Decision Date 07/24/1985
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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