The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Dilation Set, Reducers, Thread Sleeves, Distance Holders.
| Device ID | K946359 |
| 510k Number | K946359 |
| Device Name: | KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| 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 | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-30 |
| Decision Date | 1995-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551257531 | K946359 | 000 |
| 04048551120286 | K946359 | 000 |
| 04048551120293 | K946359 | 000 |
| 04048551120323 | K946359 | 000 |
| 04048551120330 | K946359 | 000 |
| 04048551120347 | K946359 | 000 |
| 04048551120354 | K946359 | 000 |
| 04048551120361 | K946359 | 000 |
| 04048551120378 | K946359 | 000 |
| 04048551120385 | K946359 | 000 |
| 04048551120392 | K946359 | 000 |
| 04048551120408 | K946359 | 000 |
| 04048551120415 | K946359 | 000 |
| 04048551120422 | K946359 | 000 |
| 04048551120453 | K946359 | 000 |
| 04048551257524 | K946359 | 000 |
| 04048551120279 | K946359 | 000 |