The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz 27086kc Ultrasonic Lithotri.
| Device ID | K843101 |
| 510k Number | K843101 |
| Device Name: | KARL STORZ 27086KC ULTRASONIC LITHOTRI |
| Classification | Lithotriptor, Ultrasonic |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Contact | Norman Silbertrust |
| Correspondent | Norman Silbertrust KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Product Code | FEO |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-07 |
| Decision Date | 1984-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551079775 | K843101 | 000 |
| 04048551079751 | K843101 | 000 |
| 04048551079799 | K843101 | 000 |
| 04048551079621 | K843101 | 000 |