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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Deklene; DEKNATEL; MULTIPLE STERILE ABSORABLE SUTURES; OPTHAMEND
Classification Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Product Code: GAW
Device Class: 2
Regulation Number: 878.5010
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: Teleflex Medical de Mexico, S. de R.L. de C.V.
Registered Establishment Number: 3004365956
Premarket Submission Number: K930738
Owner/Operator: Teleflex
Owner/Operator Number: 9062981
Establishment Operations: Manufacturer
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