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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 K897095
Device Name DISPOSINEEDLE SHARPS DISPOSAL UNIT
Applicant
Specialites Septodont
Washington Sq.
1050 Connecticut Ave. NW
Washington,  DC  20036
Applicant Contact PETER S REICHERTZ
Correspondent
Specialites Septodont
Washington Sq.
1050 Connecticut Ave. NW
Washington,  DC  20036
Correspondent Contact PETER S REICHERTZ
Regulation Number880.5570
Classification Product Code
MMK  
Date Received12/21/1989
Decision Date 01/17/1990
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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