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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K090157
Device Name ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5.
Applicant
Wcm Waste & Compliance Management, Inc.
1330 Connecticut Ave. N.W
Washington,  DC  20036
Applicant Contact SARA BETH WATSON
Correspondent
Wcm Waste & Compliance Management, Inc.
1330 Connecticut Ave. N.W
Washington,  DC  20036
Correspondent Contact SARA BETH WATSON
Regulation Number880.5570
Classification Product Code
MMK  
Date Received01/22/2009
Decision Date 05/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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