The following data is part of a premarket notification filed by Breg, Inc. with the FDA for Pain Care 2000.
| Device ID | K983454 |
| 510k Number | K983454 |
| Device Name: | PAIN CARE 2000 |
| Classification | Pump, Infusion, Elastomeric |
| 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 | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-30 |
| Decision Date | 1998-12-16 |