The following data is part of a premarket notification filed by Ludlow Technical Products with the FDA for Ludlow Technical Products, Electrode, Electrosurgical, Disposable Pediatric Dispersive Electrodes; With And Without Cord.
| Device ID | K973110 |
| 510k Number | K973110 |
| Device Name: | LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORD |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LUDLOW TECHNICAL PRODUCTS TWO LUDLOW PARK P.O. BOX 297 Chicopee, MA 01021 -0297 |
| Contact | Patrick A Malia |
| Correspondent | Patrick A Malia LUDLOW TECHNICAL PRODUCTS TWO LUDLOW PARK P.O. BOX 297 Chicopee, MA 01021 -0297 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-20 |
| Decision Date | 1997-10-21 |
| Summary: | summary |