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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Fluid Delivery
510(k) Number K915560
Device Name LO-PROFILE EXTENSION SET
Applicant
DOUGLAS MEDICAL PRODUCTS CORP.
345 DUNBAR RD.
MUNDELEIN,  IL  60060
Applicant Contact DOUGLAS JOHNSON
Correspondent
DOUGLAS MEDICAL PRODUCTS CORP.
345 DUNBAR RD.
MUNDELEIN,  IL  60060
Correspondent Contact DOUGLAS JOHNSON
Regulation Number880.5440
Classification Product Code
FPK  
Date Received12/11/1991
Decision Date 05/14/1992
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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