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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 K922468
Device Name ANGEL WING SETS -- MODIFIED
Applicant
Mbo Laboratories, Inc.
P.O. Box 948
110 Middlesex St.
North Chelmsford,  MA  01863
Applicant Contact J. B BLECHER
Correspondent
Mbo Laboratories, Inc.
P.O. Box 948
110 Middlesex St.
North Chelmsford,  MA  01863
Correspondent Contact J. B BLECHER
Regulation Number862.1675
Classification Product Code
GIM  
Date Received05/13/1992
Decision Date 07/10/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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