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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K983223
Device Name DENTAL STERLIZATION TRAY/CASSETTE
Applicant
Brasseler USA I, L.P.
1679 Kellogg Springs Dr.
Atlanta,  GA  30338
Applicant Contact COURTNEY S PARADICE
Correspondent
Brasseler USA I, L.P.
1679 Kellogg Springs Dr.
Atlanta,  GA  30338
Correspondent Contact COURTNEY S PARADICE
Regulation Number880.6850
Classification Product Code
FRG  
Date Received09/14/1998
Decision Date 01/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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