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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K232246
Device Name 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture
Applicant
M/s. Meril Endo Surgery Private Limited.
Third Floor, E1-E3, Meril Park, Survey # 135/2/B & 174/2
Muktanand Marg, Chala
Vapi,  IN 396191
Applicant Contact Umesh Sharma
Correspondent
M/s. Meril Endo Surgery Private Limited.
Third Floor, E1-E3, Meril Park, Survey # 135/2/B & 174/2
Muktanand Marg, Chala
Vapi,  IN 396191
Correspondent Contact Asma Shaikh
Regulation Number878.4840
Classification Product Code
NEW  
Subsequent Product Code
GAM  
Date Received07/28/2023
Decision Date 04/25/2024
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
Predetermined Change
Control Plan Authorized		 No
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