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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lavage, Jet
510(k) Number K926337
Device Name BONE LAVAGE SYSTEM
Applicant
Innovative Surgical Devices Corp.
413 S. Martha St.
Stillwater,  MN  55082
Applicant Contact KAREN M ROCHE
Correspondent
Innovative Surgical Devices Corp.
413 S. Martha St.
Stillwater,  MN  55082
Correspondent Contact KAREN M ROCHE
Regulation Number880.5475
Classification Product Code
FQH  
Date Received12/17/1992
Decision Date 06/11/1993
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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