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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K942989
Device Name OCR II & OCM II
Applicant
Chambermaid Products Co.
3410 SE 16th Pl.
Cape Coral,  FL  33904
Applicant Contact WILLIAM E O'NEAL
Correspondent
Chambermaid Products Co.
3410 SE 16th Pl.
Cape Coral,  FL  33904
Correspondent Contact WILLIAM E O'NEAL
Regulation Number880.6880
Classification Product Code
FLE  
Date Received06/20/1994
Decision Date 07/07/1995
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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