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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Jaw Repositioning
510(k) Number K945820
Device Name DESRA
Applicant
D.S.R.A., Inc.
2594 E. Lake Lansing Rd..
East Lansing,  MI  48823
Applicant Contact VICTOR KINGERY
Correspondent
D.S.R.A., Inc.
2594 E. Lake Lansing Rd..
East Lansing,  MI  48823
Correspondent Contact VICTOR KINGERY
Regulation Number872.5570
Classification Product Code
LQZ  
Date Received11/28/1994
Decision Date 06/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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