The following data is part of a premarket notification filed by Squibb Diagnostics with the FDA for Biceps Electrocautery System.
| Device ID | K823755 |
| 510k Number | K823755 |
| Device Name: | BICEPS ELECTROCAUTERY SYSTEM |
| Classification | Apparatus, Electrosurgical |
| Applicant | SQUIBB DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HAM |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-14 |
| Decision Date | 1983-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026704599875 | K823755 | 000 |
| 44026704599880 | K823755 | 000 |
| 44026704599859 | K823755 | 000 |
| 24026704662122 | K823755 | 000 |
| 34026704662112 | K823755 | 000 |
| 24026704599879 | K823755 | 000 |