The following data is part of a premarket notification filed by Breg, Inc. with the FDA for Polar Pump, Model 500.
| Device ID | K913729 |
| 510k Number | K913729 |
| Device Name: | POLAR PUMP, MODEL 500 |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | BREG, INC. 344 22ND ST. Costa Mesa, CA 92627 |
| Contact | Nancy A Willcox |
| Correspondent | Nancy A Willcox BREG, INC. 344 22ND ST. Costa Mesa, CA 92627 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-20 |
| Decision Date | 1991-10-18 |