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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K200559
Device Name CarpX
Applicant
PAVmed, Inc.
New York,  NY  10165
Applicant Contact Lishan Aklog
Correspondent
Hogan Lovells US LLP
1735 Market Street, Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/03/2020
Decision Date 04/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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