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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, irrigation
510(k) Number K841362
Device Name TIDAL DISTENSION IRRIGATION SET
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Regulation Number878.4200
Classification Product Code
GBX  
Date Received04/02/1984
Decision Date 08/02/1984
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
Recalls CDRH Recalls
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