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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 K990020
Device Name TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC
Applicant
Te ME NA S.A.R.L.
21981 U.S. 19n
Clearwater,  FL  33765
Applicant Contact DONALD F RYAN
Correspondent
Te ME NA S.A.R.L.
21981 U.S. 19n
Clearwater,  FL  33765
Correspondent Contact DONALD F RYAN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/04/1999
Decision Date 06/24/1999
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
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