Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device suture, recombinant technology
Regulation Description Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
Definition Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.
Product CodeNWJ
Regulation Number 878.4494
Device Class 2


Premarket Reviews
ManufacturerDecision
TEPHA, INC.
  SUBSTANTIALLY EQUIVALENT 1

-
-