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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K904663
Device Name AUTO SASH (TM)
Applicant
Block Medical, Inc.
5957 Landau Ct.
Carlsbad,  CA  92008
Applicant Contact GREGORY E SANCOFF
Correspondent
Block Medical, Inc.
5957 Landau Ct.
Carlsbad,  CA  92008
Correspondent Contact GREGORY E SANCOFF
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/12/1990
Decision Date 11/23/1992
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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