The following data is part of a premarket notification filed by Spenco Medical Corp. with the FDA for Spenco Cryopress.
| Device ID | K820906 |
| 510k Number | K820906 |
| Device Name: | SPENCO CRYOPRESS |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | SPENCO MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-01 |
| Decision Date | 1982-05-13 |