The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Mitek Electrosurgical System For Arthroscopic Use.
| Device ID | K963783 |
| 510k Number | K963783 |
| Device Name: | MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | Edward F Kent |
| Correspondent | Edward F Kent ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-20 |
| Decision Date | 1996-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705009053 | K963783 | 000 |