The following data is part of a premarket notification filed by Osteogenics Biomedical, Inc. with the FDA for Cytoplast Ptfe Suture.
| Device ID | K072076 |
| 510k Number | K072076 |
| Device Name: | CYTOPLAST PTFE SUTURE |
| Classification | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Applicant | OSTEOGENICS BIOMEDICAL, INC. 4620 71ST ST., BLDG. 78-79 Lubbock, TX 79424 |
| Contact | Dustyn Webb |
| Correspondent | Dustyn Webb OSTEOGENICS BIOMEDICAL, INC. 4620 71ST ST., BLDG. 78-79 Lubbock, TX 79424 |
| Product Code | NBY |
| CFR Regulation Number | 878.5035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-30 |
| Decision Date | 2007-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844868041511 | K072076 | 000 |
| 00844868041504 | K072076 | 000 |
| 00844868041498 | K072076 | 000 |
| 00844868041481 | K072076 | 000 |
| 00844868041474 | K072076 | 000 |
| 00844868041467 | K072076 | 000 |
| 00844868041450 | K072076 | 000 |
| 00844868041443 | K072076 | 000 |