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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K051112
Device Name WHITTLESTONE EXPRESSER
Applicant
Whittlestone, Inc.
602 B Stone Rd.
Benicia,  CA  94510
Applicant Contact BRUCE MCKENDRY
Correspondent
Whittlestone, Inc.
602 B Stone Rd.
Benicia,  CA  94510
Correspondent Contact BRUCE MCKENDRY
Regulation Number884.5160
Classification Product Code
HGX  
Date Received05/02/2005
Decision Date 09/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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