The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for The Karl Storz 26025uc Hamou Elec Hysteroflator.
| Device ID | K912498 |
| 510k Number | K912498 |
| Device Name: | THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR |
| Classification | Insufflator, Hysteroscopic |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Contact | Robert R Giorgini |
| Correspondent | Robert R Giorgini KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-05 |
| Decision Date | 1991-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551069158 | K912498 | 000 |