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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, Diagnostic
510(k) Number K935403
Device Name WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
Applicant
J-LLOYD MEDICAL, INC.
415 COMMERCE LN., SUITE 6
WEST BERLIN,  NJ  08091
Applicant Contact JAMES L SKAGGS, SR.
Correspondent
J-LLOYD MEDICAL, INC.
415 COMMERCE LN., SUITE 6
WEST BERLIN,  NJ  08091
Correspondent Contact JAMES L SKAGGS, SR.
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/09/1993
Decision Date 05/12/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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