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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K190331
Device Name Applied Medical Laparoscopic Linear Cutter
Applicant
Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Applicant Contact Aditi Iyengar
Correspondent
Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Correspondent Contact Aditi Iyengar
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received02/14/2019
Decision Date 11/22/2019
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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