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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Positioner, Tooth, Preformed
510(k) Number K925064
Device Name RELAX-O-GUARD
Applicant
Aquatemp Service Co., Inc.
58-C S. St.
Morristown,  NJ  07960
Applicant Contact PAUL J DUDECK
Correspondent
Aquatemp Service Co., Inc.
58-C S. St.
Morristown,  NJ  07960
Correspondent Contact PAUL J DUDECK
Regulation Number872.5525
Classification Product Code
KMY  
Date Received10/06/1992
Decision Date 09/13/1993
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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