The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Modification To Autocon Ii 400 Electrosurgical Generator.
| Device ID | K062464 |
| 510k Number | K062464 |
| Device Name: | MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | James A Lee |
| Correspondent | James A Lee KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-24 |
| Decision Date | 2007-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551259191 | K062464 | 000 |
| 04048551070635 | K062464 | 000 |