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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name negative pressure wound therapy powered suction pump
510(k) Number K061788
Device Name BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
Applicant
BOEHRINGER LABORATORIES
500 E. WASHINGTON ST.
NORRISTOWN,  PA  19401
Applicant Contact CHRISTOPHER RADL
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number878.4780
Classification Product Code
OMP  
Date Received06/26/2006
Decision Date 07/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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