The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Arthrocare Dental Electrosurgery System.
| Device ID | K962445 |
| 510k Number | K962445 |
| Device Name: | ARTHROCARE DENTAL ELECTROSURGERY SYSTEM |
| Classification | Unit, Electrosurgical, And Accessories, Dental |
| Applicant | ARTHROCARE CORP. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2936 |
| Contact | Cheryl L Shea |
| Correspondent | Cheryl L Shea ARTHROCARE CORP. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2936 |
| Product Code | EKZ |
| CFR Regulation Number | 872.4920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-24 |
| Decision Date | 1996-07-30 |
| Summary: | summary |