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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 K921594
Device Name HAEMOTROL MODEL #HT-SB/6 BURETTE SET
Applicant
Haemotronic, Inc.
45 Kulick Rd.
Fairfield,  NJ  07004
Applicant Contact WILLER GHELFI
Correspondent
Haemotronic, Inc.
45 Kulick Rd.
Fairfield,  NJ  07004
Correspondent Contact WILLER GHELFI
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/03/1992
Decision Date 12/24/1992
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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