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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
510(k) Number K982304
Device Name DEVILBISS SUCTION UNIT
Applicant
SUNRISE MEDICAL HHG, INC.
100 DEVILBISS DR.
SOMERSET,  PA  15501
Applicant Contact MATT SMITH
Correspondent
SUNRISE MEDICAL HHG, INC.
100 DEVILBISS DR.
SOMERSET,  PA  15501
Correspondent Contact MATT SMITH
Regulation Number878.4780
Classification Product Code
JCX  
Date Received07/01/1998
Decision Date 09/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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