The following data is part of a premarket notification filed by Osung Mnd Co., Ltd with the FDA for Instrument Cassette (efccl1-f).
| Device ID | K141854 |
| 510k Number | K141854 |
| Device Name: | INSTRUMENT CASSETTE (EFCCL1-F) |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | OSUNG MND CO., LTD 180 S. WESTERN AVENUE, #205 Carpentersville, IL 60110 |
| Contact | Kiran Sheikh |
| Correspondent | Kiran Sheikh OSUNG MND CO., LTD 180 S. WESTERN AVENUE, #205 Carpentersville, IL 60110 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-09 |
| Decision Date | 2015-10-29 |
| Summary: | summary |