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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, balloon type
510(k) Number K802025
Device Name BALLOON RETENTION CHEST CATHETER
Applicant
LOSEFF MEDICAL DESIGNERS, LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LOSEFF MEDICAL DESIGNERS, LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4200
Classification Product Code
GBA  
Date Received08/20/1980
Decision Date 09/26/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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