The following data is part of a premarket notification filed by Seabrook Medical Systems, Inc. with the FDA for Golden Thermal(r).
| Device ID | K914182 |
| 510k Number | K914182 |
| Device Name: | GOLDEN THERMAL(R) |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | SEABROOK MEDICAL SYSTEMS, INC. 673 WILMER AVE. Cincinnati, OH 45226 -1859 |
| Contact | Ronald L French |
| Correspondent | Ronald L French 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 | 1991-09-18 |
| Decision Date | 1991-10-18 |