The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Model Cbc-1 Coa Comp Anti-sticking Bipolar Coag..
| Device ID | K871077 |
| 510k Number | K871077 |
| Device Name: | MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG. |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Contact | Cosman, Phd |
| Correspondent | Cosman, Phd RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-18 |
| Decision Date | 1987-06-12 |