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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K910159
Device Name WINGED ADMININ. SET W/NON-CORING NEEDLE
Applicant
Dmd Products
16 Chicory Ln.
San Carlos,  CA  94070
Applicant Contact JOHN T WRIGHT
Correspondent
Dmd Products
16 Chicory Ln.
San Carlos,  CA  94070
Correspondent Contact JOHN T WRIGHT
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/15/1991
Decision Date 09/06/1991
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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