The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Model 27084 Uromat For Urological Irrigation.
| Device ID | K883173 |
| 510k Number | K883173 |
| Device Name: | MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Contact | Robert Giorgini |
| Correspondent | Robert Giorgini KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-27 |
| Decision Date | 1988-10-25 |