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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 K875297
Device Name JAMES TENDOS (SYRINGE HOLDER)
Applicant
Med-Text Intl.
Box 158
S-24222 Horby,  SE
Applicant Contact RON GUSTAFSON
Correspondent
Med-Text Intl.
Box 158
S-24222 Horby,  SE
Correspondent Contact RON GUSTAFSON
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/30/1987
Decision Date 04/19/1988
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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