The following data is part of a premarket notification filed by Bioform, Inc. with the FDA for Coaptite Tissue Marker And Coaptite Fn Tissue Marker.
| Device ID | K012955 |
| 510k Number | K012955 |
| Device Name: | COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER |
| Classification | Marker, Radiographic, Implantable |
| Applicant | BIOFORM, INC. 4133 COURTNEY ROAD, #10 Franksville, WI 53126 |
| Contact | Victor M Bowers |
| Correspondent | Victor M Bowers BIOFORM, INC. 4133 COURTNEY ROAD, #10 Franksville, WI 53126 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-04 |
| Decision Date | 2001-10-22 |
| Summary: | summary |