The following data is part of a premarket notification filed by Surgicare Scientific Laboratory, Inc. with the FDA for Model #2000 Hi-temp & #3000 Low-temp.
| Device ID | K822513 |
| 510k Number | K822513 |
| Device Name: | MODEL #2000 HI-TEMP & #3000 LOW-TEMP |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SURGICARE SCIENTIFIC LABORATORY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-20 |
| Decision Date | 1982-09-21 |