The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Hysteromat Ii.
| Device ID | K000806 |
| 510k Number | K000806 |
| Device Name: | KARL STORZ HYSTEROMAT II |
| Classification | Insufflator, Hysteroscopic |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Kevin Kennan |
| Correspondent | Kevin Kennan KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-13 |
| Decision Date | 2000-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551067888 | K000806 | 000 |