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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 K852606
Device Name FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20)
Applicant
Infarkem Corp.
280 N. Central Ave.
Hartsdale,  NY  10530
Applicant Contact VALERIO VALERI
Correspondent
Infarkem Corp.
280 N. Central Ave.
Hartsdale,  NY  10530
Correspondent Contact VALERIO VALERI
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/19/1985
Decision Date 09/19/1985
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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