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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K981602
Device Name DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR
Applicant
Sunrise Medical Hhg, Inc.
100 Devilbiss Dr.
Somerset,  PA  15501
Applicant Contact ALLAN R JONES
Correspondent
Sunrise Medical Hhg, Inc.
100 Devilbiss Dr.
Somerset,  PA  15501
Correspondent Contact ALLAN R JONES
Regulation Number878.4780
Classification Product Code
BTA  
Date Received05/05/1998
Decision Date 07/17/1998
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
Predetermined Change
Control Plan Authorized		 No
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