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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 K953231
Device Name PPMI-(XXX) AND PPMO-(XXX)
Applicant
Patriot Products, Inc.
1475 N. M-52, Suite 101
Owosso,  MI  48867
Applicant Contact CINDY A LILEY
Correspondent
Patriot Products, Inc.
1475 N. M-52, Suite 101
Owosso,  MI  48867
Correspondent Contact CINDY A LILEY
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/10/1995
Decision Date 09/07/1995
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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