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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyamide
510(k) Number K261484
Device Name Tissue Approximation System
Applicant
Tas Medical, Inc.
9100 Conroy Windermere Rd.
Suite 200
Windermere,  FL  34786
Applicant Contact Thomas Kramer
Correspondent
Oconnell Regulatory Consultants, Inc.
44 Oak St.
Stoneham,  MA  02180
Correspondent Contact Maureen OConnell
Regulation Number878.5020
Classification Product Code
GAR  
Date Received05/05/2026
Decision Date 06/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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