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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K946170
Device Name COMFORT-Q SUBCUTANEOUS INJECTION SETS
Applicant
B. Braun of America, Inc.
824 Twelfth Ave.
P.O. Box 4027
Bethlehem,  PA  18018
Applicant Contact MARK S ALSBERGE
Correspondent
B. Braun of America, Inc.
824 Twelfth Ave.
P.O. Box 4027
Bethlehem,  PA  18018
Correspondent Contact MARK S ALSBERGE
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/19/1994
Decision Date 11/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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