The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Glanz Carcinoma Gauge, Ksea.
| Device ID | K954348 |
| 510k Number | K954348 |
| Device Name: | GLANZ CARCINOMA GAUGE, KSEA |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Betty Johnson |
| Correspondent | Betty Johnson KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-18 |
| Decision Date | 1995-11-15 |