The following data is part of a premarket notification filed by Suncoast Medical Manufacturers, Inc. with the FDA for Replace-a-tip Low Temp. Cautery.
| Device ID | K840434 |
| 510k Number | K840434 |
| Device Name: | REPLACE-A-TIP LOW TEMP. CAUTERY |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SUNCOAST MEDICAL MANUFACTURERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-01 |
| Decision Date | 1984-04-25 |