The following data is part of a premarket notification filed by Demetech Corp. with the FDA for Demetech Polydioxanone Synthetic Monofilament (pdo) Absorbable Suture.
Device ID | K082097 |
510k Number | K082097 |
Device Name: | DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE |
Classification | Suture, Surgical, Absorbable, Polydioxanone |
Applicant | DEMETECH CORP. 8935 NW 27TH STREET Miami, FL 33172 |
Contact | Anthony J Dimercurio |
Correspondent | Anthony J Dimercurio DEMETECH CORP. 8935 NW 27TH STREET Miami, FL 33172 |
Product Code | NEW |
CFR Regulation Number | 878.4840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-07-24 |
Decision Date | 2010-01-08 |
Summary: | summary |