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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K130172
Device Name BELIMED STEAM STERILIZER MST-V
Applicant
Belimed, Inc.
2284 Clements Ferry Rd.
Charleston,  SC  29492
Applicant Contact JAY UPCHURCH
Correspondent
Belimed, Inc.
2284 Clements Ferry Rd.
Charleston,  SC  29492
Correspondent Contact JAY UPCHURCH
Regulation Number880.6880
Classification Product Code
FLE  
Date Received01/24/2013
Decision Date 09/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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