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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 K910142
Device Name SPARK KIT(R), MODIFICATION
Applicant
Lyphomed, Inc.
2045 N. Cornell Ave.
Melrose Park,  IL  60160
Applicant Contact DONALD E BAKER
Correspondent
Lyphomed, Inc.
2045 N. Cornell Ave.
Melrose Park,  IL  60160
Correspondent Contact DONALD E BAKER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/14/1991
Decision Date 05/14/1991
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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