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 |