The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Mccain Monopolar & Bipolar Cautery.
| Device ID | K881403 |
| 510k Number | K881403 |
| Device Name: | MCCAIN MONOPOLAR & BIPOLAR CAUTERY |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Debra A Powers |
| Correspondent | Debra A Powers WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-04 |
| Decision Date | 1988-06-22 |