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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 K970726
Device Name VAPOCIDE
Applicant
Cottrell, Ltd.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact MARY MC NAMARA-CULLINANE
Correspondent
Cottrell, Ltd.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact MARY MC NAMARA-CULLINANE
Regulation Number880.6885
Classification Product Code
MED  
Date Received02/28/1997
Decision Date 05/18/1998
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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