The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Mvm 7.5 French Flexible Choledochoscope.
| Device ID | K972926 |
| 510k Number | K972926 |
| Device Name: | MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE |
| Classification | Choledochoscope And Accessories, Flexible/rigid |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Kevin A Kennan |
| Correspondent | Kevin A Kennan KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | FBN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-08 |
| Decision Date | 1997-10-08 |
| Summary: | summary |