The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Cystoscope (78faj)endoscope,fiberoptic (78gdb).
| Device ID | K945185 |
| 510k Number | K945185 |
| Device Name: | CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB) |
| Classification | Cystourethroscope |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Marika Anderson |
| Correspondent | Marika Anderson KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | FBO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-24 |
| Decision Date | 1995-05-03 |