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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 K822406
Device Name BOSTON SOLUTION INFUSION SETS
Applicant
The Boston Medical Group
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
The Boston Medical Group
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/10/1982
Decision Date 09/30/1982
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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