The following data is part of a premarket notification filed by Breg, Inc. with the FDA for Modification To Polar Care 500.
| Device ID | K070402 |
| 510k Number | K070402 |
| Device Name: | MODIFICATION TO POLAR CARE 500 |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | BREG, INC. 2611 COMMERCE WAY Vista, CA 92083 |
| Contact | Kathleen Barber |
| Correspondent | Kathleen Barber BREG, INC. 2611 COMMERCE WAY Vista, CA 92083 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-12 |
| Decision Date | 2007-03-29 |