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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 K141200
Device Name PADI-LOCK
Applicant
PADI-LOCK, LLC
55 NORTHERN BLVD, STE 200
GREAT NECK,  NY  11021
Applicant Contact MARIA GRIFFIN
Correspondent
PADI-LOCK, LLC
55 NORTHERN BLVD, STE 200
GREAT NECK,  NY  11021
Correspondent Contact MARIA GRIFFIN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/09/2014
Decision Date 10/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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