The following data is part of a premarket notification filed by Co-medical, Inc. with the FDA for Sterile Soft Tissue Biopsy Needle.
| Device ID | K854003 |
| 510k Number | K854003 |
| Device Name: | STERILE SOFT TISSUE BIOPSY NEEDLE |
| Classification | Brush, Biopsy, General & Plastic Surgery |
| Applicant | CO-MEDICAL, INC. 2240 LEE ST. Lakewood, CO 80215 |
| Contact | Gary Brunner |
| Correspondent | Gary Brunner CO-MEDICAL, INC. 2240 LEE ST. Lakewood, CO 80215 |
| Product Code | GEE |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-30 |
| Decision Date | 1985-10-18 |