The following data is part of a premarket notification filed by Divi Intl. Co. with the FDA for Paramed Paraffin Warmer.
| Device ID | K991427 |
| 510k Number | K991427 |
| Device Name: | PARAMED PARAFFIN WARMER |
| Classification | Bath, Paraffin |
| Applicant | DIVI INTL. CO. 12188 S.W. 128TH ST. Miami, FL 33186 |
| Contact | Mike Vidal |
| Correspondent | Mike Vidal DIVI INTL. CO. 12188 S.W. 128TH ST. Miami, FL 33186 |
| Product Code | IMC |
| CFR Regulation Number | 890.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-23 |
| Decision Date | 1999-08-13 |