The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Mvm 7.5 French Flexible Ureteroscope.
Device ID | K982905 |
510k Number | K982905 |
Device Name: | MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE |
Classification | Ureteroscope And Accessories, Flexible/rigid |
Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Contact | Kevin A Kennan |
Correspondent | Kevin A Kennan KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Product Code | FGB |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-18 |
Decision Date | 1998-10-05 |
Summary: | summary |