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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K920755
Device Name L-CATH PEEL AWAY SYSTEM CATHETER
Applicant
LUTHER MEDICAL PRODUCTS, INC.
14332 CHAMBERS RD.
TUSTIN,  CA  92780 -6912
Applicant Contact BARBARA C LUTHER
Correspondent
LUTHER MEDICAL PRODUCTS, INC.
14332 CHAMBERS RD.
TUSTIN,  CA  92780 -6912
Correspondent Contact BARBARA C LUTHER
Regulation Number880.5970
Classification Product Code
LJS  
Date Received02/19/1992
Decision Date 06/07/1993
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
Recalls CDRH Recalls
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