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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilant, Medical Devices
510(k) Number K972708
Device Name ENDO-SPOR PLUS / HYPROCIDE
Applicant
COTTRELL, LTD.
7399 SOUTH TUCSON WAY
ENGLEWOOD,  CO  80112
Applicant Contact JACK SCOVILLE
Correspondent
COTTRELL, LTD.
7399 SOUTH TUCSON WAY
ENGLEWOOD,  CO  80112
Correspondent Contact JACK SCOVILLE
Regulation Number880.6885
Classification Product Code
MED  
Date Received07/21/1997
Decision Date 09/13/1999
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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