The following data is part of a premarket notification filed by Tri W-g, Inc. with the FDA for R1363 Paraffin.
| Device ID | K861346 |
| 510k Number | K861346 |
| Device Name: | R1363 PARAFFIN |
| Classification | Bath, Paraffin |
| Applicant | TRI W-G, INC. P.O. BOX 905 Valley City, ND 58072 |
| Contact | John Weber |
| Correspondent | John Weber TRI W-G, INC. P.O. BOX 905 Valley City, ND 58072 |
| Product Code | IMC |
| CFR Regulation Number | 890.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-07 |
| Decision Date | 1986-05-02 |