The following data is part of a premarket notification filed by Thermo Forma, Inc. with the FDA for Thermo Forma, Cryomed, Controlled Rate Freezers; Models # 7456, 7457, 7458,7459,7475,7476.
| Device ID | K021042 |
| 510k Number | K021042 |
| Device Name: | THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476 |
| Classification | Accessory, Assisted Reproduction |
| Applicant | THERMO FORMA, INC. 401 MILLCREEK RD. Marietta, OH 45750 |
| Contact | Richard L Miller |
| Correspondent | Richard L Miller THERMO FORMA, INC. 401 MILLCREEK RD. Marietta, OH 45750 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-01 |
| Decision Date | 2002-05-15 |
| Summary: | summary |