The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for The Karl Storz Uromat(tm).
| Device ID | K940983 |
| 510k Number | K940983 |
| Device Name: | THE KARL STORZ UROMAT(TM) |
| Classification | System, Irrigation, Urological |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | Paul L Sumner |
| Correspondent | Paul L Sumner KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 ROBERTS BLVD. Kennesaw, GA 30144 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-01 |
| Decision Date | 1994-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551082942 | K940983 | 000 |