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K Number
DEN060003
Device Name
TEPHAFLEX ABSORBABLE SUTURE
Manufacturer
TEPHA, INC.
Date Cleared
2007-02-08

(272 days)

Product Code
NWJ
Regulation Number
878.4494
Type
Post-NSE
Panel
SU
Reference & Predicate Devices
N/A
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Intended Use
Device Description
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§ 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.

(a)
Identification. An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).