The following data is part of a premarket notification filed by Seabrook Medical Systems, Inc. with the FDA for Dual-temp(tm) Cooling/warming Unit.
| Device ID | K882310 |
| 510k Number | K882310 |
| Device Name: | DUAL-TEMP(TM) COOLING/WARMING UNIT |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | SEABROOK MEDICAL SYSTEMS, INC. 673 WILMER AVE. Cincinnati, OH 45226 -1859 |
| Contact | Mark J Buch |
| Correspondent | Mark J Buch SEABROOK MEDICAL SYSTEMS, INC. 673 WILMER AVE. Cincinnati, OH 45226 -1859 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-03 |
| Decision Date | 1988-09-23 |