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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 K002696
Device Name WHITTLESTONE BREASTPUMP
Applicant
WHITTLESTONE, INC.
601A STONE RD.
BENICIA,  CA  94510
Applicant Contact BRUCE MCKENDRY
Correspondent
WHITTLESTONE, INC.
601A STONE RD.
BENICIA,  CA  94510
Correspondent Contact BRUCE MCKENDRY
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/30/2000
Decision Date 03/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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