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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Surgical, General & Plastic Surgery
510(k) Number K871384
Device Name APEX SUCTION CURETTE
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 Number878.4800
Classification Product Code
GEA  
Date Received04/07/1987
Decision Date 05/22/1987
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
Predetermined Change
Control Plan Authorized		 No
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