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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mirror, Mouth
510(k) Number K935687
Device Name NIL
Applicant
Dentalsafe Systems Pty., Ltd.
2 Gardeners Rd.
Kingsford Nsw 2032
Sydney, Australia,  AU 2032
Applicant Contact SYDNEY STEEN
Correspondent
Dentalsafe Systems Pty., Ltd.
2 Gardeners Rd.
Kingsford Nsw 2032
Sydney, Australia,  AU 2032
Correspondent Contact SYDNEY STEEN
Regulation Number872.4565
Classification Product Code
EAX  
Subsequent Product Codes
ECP   EFL  
Date Received11/29/1993
Decision Date 02/03/1994
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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