The following data is part of a premarket notification filed by Implant Direct Sybron Manufacturing , Llc with the FDA for Interactive Complete Surgical Tray.
| Device ID | K142519 |
| 510k Number | K142519 |
| Device Name: | InterActive Complete Surgical Tray |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Implant Direct Sybron Manufacturing , LLC 27030 Malibu Hills Rd Calabasas Hills, CA 91301 |
| Contact | Debleena Sinha |
| Correspondent | Debleena Sinha Implant Direct Sybron Manufacturing , LLC 27030 Malibu Hills Rd Calabasas Hills, CA 91301 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-08 |
| Decision Date | 2015-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841307117513 | K142519 | 000 |
| 10841307117506 | K142519 | 000 |
| 10841307117490 | K142519 | 000 |
| 10841307117483 | K142519 | 000 |