The following data is part of a premarket notification filed by Micromed, Inc. with the FDA for Rebuilder Bucket System.
| Device ID | K882980 |
| 510k Number | K882980 |
| Device Name: | REBUILDER BUCKET SYSTEM |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | MICROMED, INC. THE KILN 15 BRICKYARD ROAD Essex Junction, VT 05452 |
| Contact | David B Phillips |
| Correspondent | David B Phillips MICROMED, INC. THE KILN 15 BRICKYARD ROAD Essex Junction, VT 05452 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-15 |
| Decision Date | 1989-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866650000315 | K882980 | 000 |