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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor
510(k) Number K943875
Device Name VILLALTA RETRACTOR
Applicant
Hct, Inc.
6443 W. 10th St.
Suite 202
Indianapolis,  IN  46214
Applicant Contact MICHAEL L EINTERZ
Correspondent
Hct, Inc.
6443 W. 10th St.
Suite 202
Indianapolis,  IN  46214
Correspondent Contact MICHAEL L EINTERZ
Regulation Number878.4800
Classification Product Code
GAD  
Date Received08/08/1994
Decision Date 11/09/1994
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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