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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Regulator, Vacuum
510(k) Number K013976
Device Name BOEHRINGER MRI SUCTION REGULATORY
Applicant
Boehringer Laboratories
500 E. Washington St.
Norristown,  PA  19401
Applicant Contact JOHN KARPOWICZ
Correspondent
Boehringer Laboratories
500 E. Washington St.
Norristown,  PA  19401
Correspondent Contact JOHN KARPOWICZ
Regulation Number880.6740
Classification Product Code
KDP  
Date Received12/03/2001
Decision Date 01/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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