The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Autocon Ii 200 Electrosurgical Generator.
Device ID | K023924 |
510k Number | K023924 |
Device Name: | AUTOCON II 200 ELECTROSURGICAL GENERATOR |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Contact | James A Lee |
Correspondent | James A Lee KARL STORZ ENDOSCOPY 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 | 2002-11-25 |
Decision Date | 2003-02-21 |
Summary: | summary |