The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Model 264305-20 Electronic Endoflator.
| Device ID | K962863 |
| 510k Number | K962863 |
| Device Name: | KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR |
| Classification | Insufflator, Laparoscopic |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Renate M Maclaren |
| Correspondent | Renate M Maclaren KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-23 |
| Decision Date | 1996-11-19 |
| Summary: | summary |