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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 K881975
Device Name SET, INTRAVASCULAR
Applicant
PRIMROSE MEDICAL, INC.
20 CABOT RD.
WOBURN,  MA  01801
Applicant Contact FLETCHER LONGLEY
Correspondent
PRIMROSE MEDICAL, INC.
20 CABOT RD.
WOBURN,  MA  01801
Correspondent Contact FLETCHER LONGLEY
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/11/1988
Decision Date 07/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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