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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vacuum Sample, With Anticoagulant
510(k) Number K920184
Device Name ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD.
Applicant
Mbo Laboratories, Inc.
P.O. Box 948
110 Middlesex St.
North Chelmsford,  MA  01863
Applicant Contact JACOB B BLECHER
Correspondent
Mbo Laboratories, Inc.
P.O. Box 948
110 Middlesex St.
North Chelmsford,  MA  01863
Correspondent Contact JACOB B BLECHER
Regulation Number862.1675
Classification Product Code
GIM  
Date Received01/15/1992
Decision Date 02/18/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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