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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K924118
Device Name PROPAK
Applicant
Dental Services, Inc.
1845 Darby Dr.
Florence,  AL  35630
Applicant Contact DAVID STODDARD
Correspondent
Dental Services, Inc.
1845 Darby Dr.
Florence,  AL  35630
Correspondent Contact DAVID STODDARD
Regulation Number880.6850
Classification Product Code
KCT  
Subsequent Product Code
FRG  
Date Received08/14/1992
Decision Date 07/13/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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