The following data is part of a premarket notification filed by Karl Storz Gmbh & Co. (kst) with the FDA for Lithotriptor System Model 27080.
| Device ID | K905553 |
| 510k Number | K905553 |
| Device Name: | LITHOTRIPTOR SYSTEM MODEL 27080 |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | KARL STORZ GMBH & CO. (KST) 10111 W. JEFFERSON BLVD. Culver City, CA 90232 |
| Contact | Robert R Giorgini |
| Correspondent | Robert R Giorgini KARL STORZ GMBH & CO. (KST) 10111 W. JEFFERSON BLVD. Culver City, CA 90232 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-11 |
| Decision Date | 1991-06-04 |