The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Bougies And Dilators.
| Device ID | K950125 |
| 510k Number | K950125 |
| Device Name: | KARL STORZ BOUGIES AND DILATORS |
| Classification | Bougie, Urological |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Betty M Johnson |
| Correspondent | Betty M Johnson KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | FAX |
| Subsequent Product Code | EZN |
| Subsequent Product Code | FAH |
| Subsequent Product Code | KOE |
| CFR Regulation Number | 876.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-12 |
| Decision Date | 1995-02-07 |