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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., NW
WASHINGTON,  DC  20036
Applicant Contact SARA BETH WATSON
Correspondent
WCM WASTE & COMPLIANCE MANAGEMENT, INC.
1330 CONNECTICUT AVE., NW
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
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