The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Mvm 7.5 French Flexible Hysteroscope.
Device ID | K990411 |
510k Number | K990411 |
Device Name: | MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE |
Classification | Hysteroscope (and Accessories) |
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 | HIH |
CFR Regulation Number | 884.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-10 |
Decision Date | 1999-05-11 |
Summary: | summary |