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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: HeartStitch EL; HeartStitch MR; HeartStitch TA; NobleStitch EL; NobleStitch MR; NobleStitch TA
Classification Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Product Code: GAW
Device Class: 2
Regulation Number: 878.5010
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: Nobles Medical Technologies II, Inc.
Registered Establishment Number: 2031768
Premarket Submission Number: K113494
Owner/Operator: HeartStitch, Inc.
Owner/Operator Number: 10036047
Establishment Operations: Specification Developer
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