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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bottle, Collection, Vacuum
510(k) Number K882468
Device Name ELIMINATOR AIR FILTER
Applicant
Apex Medical, Inc.
990 Dillman Rd.
Martinsville,  IN  46151
Applicant Contact LARRY INMAN
Correspondent
Apex Medical, Inc.
990 Dillman Rd.
Martinsville,  IN  46151
Correspondent Contact LARRY INMAN
Regulation Number880.6740
Classification Product Code
KDQ  
Date Received06/15/1988
Decision Date 08/29/1988
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
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