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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Orthodontic
510(k) Number K943334
Device Name HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT
Applicant
Jay H. Geller
East Tower, Suite 600
2425 W. Olympic Blvd.
Santa Monica,  CA  90404
Applicant Contact JAY H GELLER
Correspondent
Jay H. Geller
East Tower, Suite 600
2425 W. Olympic Blvd.
Santa Monica,  CA  90404
Correspondent Contact JAY H GELLER
Regulation Number872.5410
Classification Product Code
DZC  
Date Received07/12/1994
Decision Date 10/05/1994
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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