The following data is part of a premarket notification filed by Osteogenics Biomedical, Inc. with the FDA for Cytoplast Suture; Cs-0318, Cs-0416, Cs-0418, Cs-0513, Cs-0513pc, Cs-0516hc.
| Device ID | K003028 |
| 510k Number | K003028 |
| Device Name: | CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC |
| Classification | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Applicant | OSTEOGENICS BIOMEDICAL, INC. 3234 64TH ST. Lubbock, TX 79413 |
| Contact | Chad Bartee |
| Correspondent | Chad Bartee OSTEOGENICS BIOMEDICAL, INC. 3234 64TH ST. Lubbock, TX 79413 |
| Product Code | NBY |
| CFR Regulation Number | 878.5035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-28 |
| Decision Date | 2000-11-24 |