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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 K991612
Device Name STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G
Applicant
Sterilogic Waste Systems, Inc.
9948 Kistler Valley Rd., #102
Kempton,  PA  19529 -0084
Applicant Contact CALVIN A ODHNER
Correspondent
Sterilogic Waste Systems, Inc.
9948 Kistler Valley Rd., #102
Kempton,  PA  19529 -0084
Correspondent Contact CALVIN A ODHNER
Regulation Number880.5570
Classification Product Code
MMK  
Date Received05/10/1999
Decision Date 05/28/1999
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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