The following data is part of a premarket notification filed by Planer Plc with the FDA for Kryo Art Controlled Rate Freezer.
| Device ID | K032086 |
| 510k Number | K032086 |
| Device Name: | KRYO ART CONTROLLED RATE FREEZER |
| Classification | Accessory, Assisted Reproduction |
| Applicant | PLANER PLC 200 GREGORY LANE SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Contact | David S Schlerf |
| Correspondent | David S Schlerf PLANER PLC 200 GREGORY LANE SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-07 |
| Decision Date | 2004-03-19 |
| Summary: | summary |