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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthpiece, Saliva Ejector
510(k) Number K935758
Device Name HYGOFLEX SALIVA-EJECTOR
Applicant
J.H.Orsing AB
P.O. Box 16077 Torbornavagen
26
Raa,  SE S-25016
Applicant Contact KERSTIN ORSING
Correspondent
J.H.Orsing AB
P.O. Box 16077 Torbornavagen
26
Raa,  SE S-25016
Correspondent Contact KERSTIN ORSING
Regulation Number872.6640
Classification Product Code
DYN  
Date Received11/26/1993
Decision Date 03/21/1994
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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