The following data is part of a premarket notification filed by Breg, Inc. with the FDA for Polar Care (model 500/50000).
| Device ID | K961855 |
| 510k Number | K961855 |
| Device Name: | POLAR CARE (MODEL 500/50000) |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | BREG, INC. 2611 COMMERCE WAY Vista, CA 92083 |
| Contact | James T Kelley |
| Correspondent | James T Kelley BREG, INC. 2611 COMMERCE WAY Vista, CA 92083 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-14 |
| Decision Date | 1996-08-09 |