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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lavage, Jet
510(k) Number K942886
Device Name SIMPULSE SOLO SUCTION IRRIGATOR
Applicant
Davol Inc., Sub. C. R. Bard, Inc.
100 Sockanossett Crossroad
Canston,  RI  02920
Applicant Contact ANNETTE M FAGNANT
Correspondent
Davol Inc., Sub. C. R. Bard, Inc.
100 Sockanossett Crossroad
Canston,  RI  02920
Correspondent Contact ANNETTE M FAGNANT
Regulation Number880.5475
Classification Product Code
FQH  
Date Received06/17/1994
Decision Date 07/19/1994
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
Recalls CDRH Recalls
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