The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Stent Applicator Forceps.
| Device ID | K950965 |
| 510k Number | K950965 |
| Device Name: | KARL STORZ STENT APPLICATOR FORCEPS |
| Classification | Bronchoscope (flexible Or Rigid) |
| 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 | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-02 |
| Decision Date | 1995-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026704205028 | K950965 | 000 |
| 24026704715538 | K950965 | 000 |
| 24026704715545 | K950965 | 000 |
| 24026704715552 | K950965 | 000 |
| 24026704715569 | K950965 | 000 |
| 24026704204988 | K950965 | 000 |
| 24026704204995 | K950965 | 000 |
| 24026704205008 | K950965 | 000 |
| 24026704205015 | K950965 | 000 |
| 24026704205022 | K950965 | 000 |
| 04026704204984 | K950965 | 000 |
| 04026704204991 | K950965 | 000 |
| 04026704205004 | K950965 | 000 |
| 04026704205011 | K950965 | 000 |
| 24026704715521 | K950965 | 000 |