The following data is part of a premarket notification filed by Demetech Corp. with the FDA for Demetech Silk Nonabsorbable Suture.
Device ID | K023029 |
510k Number | K023029 |
Device Name: | DEMETECH SILK NONABSORBABLE SUTURE |
Classification | Suture, Nonabsorbable, Silk |
Applicant | DEMETECH CORP. 12119 SW 131 AVE. Miami, FL 33186 |
Contact | Luis Arguello |
Correspondent | Luis Arguello DEMETECH CORP. 12119 SW 131 AVE. Miami, FL 33186 |
Product Code | GAP |
CFR Regulation Number | 878.5030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-09-11 |
Decision Date | 2002-11-25 |
Summary: | summary |