The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz -endoscope Sterilization Trays, Models 39402as, 39301hcts, 39301bs.
| Device ID | K090818 |
| 510k Number | K090818 |
| Device Name: | KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Contact | Monika Campbell |
| Correspondent | Monika Campbell KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-25 |
| Decision Date | 2009-08-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551401460 | K090818 | 000 |
| 04048551243008 | K090818 | 000 |
| 04048551254172 | K090818 | 000 |
| 04048551254189 | K090818 | 000 |
| 04048551254202 | K090818 | 000 |
| 04048551254219 | K090818 | 000 |
| 04048551254233 | K090818 | 000 |
| 04048551254240 | K090818 | 000 |
| 04048551268155 | K090818 | 000 |
| 04048551268223 | K090818 | 000 |
| 04048551271339 | K090818 | 000 |
| 04048551271346 | K090818 | 000 |
| 04048551271353 | K090818 | 000 |
| 04048551338391 | K090818 | 000 |
| 04048551401439 | K090818 | 000 |
| 04048551401446 | K090818 | 000 |
| 04048551401453 | K090818 | 000 |
| 04048551157602 | K090818 | 000 |