The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Olympus Sterilization Trays.
| Device ID | K033222 |
| 510k Number | K033222 |
| Device Name: | OLYMPUS STERILIZATION TRAYS |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Tina Steffanie-oak |
| Correspondent | Tina Steffanie-oak OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-03 |
| Decision Date | 2004-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761077125 | K033222 | 000 |
| 04042761030236 | K033222 | 000 |
| 04042761030229 | K033222 | 000 |
| 04042761029933 | K033222 | 000 |
| 04042761029766 | K033222 | 000 |
| 04042761029674 | K033222 | 000 |
| 04042761028844 | K033222 | 000 |
| 04042761009652 | K033222 | 000 |
| 04042761009645 | K033222 | 000 |
| 04042761030243 | K033222 | 000 |
| 04042761030250 | K033222 | 000 |
| 04042761066969 | K033222 | 000 |
| 04042761063241 | K033222 | 000 |
| 04042761051248 | K033222 | 000 |
| 04042761035361 | K033222 | 000 |
| 04042761030885 | K033222 | 000 |
| 04042761030304 | K033222 | 000 |
| 04042761030298 | K033222 | 000 |
| 04042761030267 | K033222 | 000 |
| 04042761009560 | K033222 | 000 |