The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Model 27080 Calcutript Electrohydraulic Lithr Sys.
| Device ID | K883189 |
| 510k Number | K883189 |
| Device Name: | MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS |
| Classification | Lithotriptor, Electro-hydraulic |
| 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 | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-28 |
| Decision Date | 1989-02-13 |