The following data is part of a premarket notification filed by Shenzhen Comfort Technology Co., Ltd. with the FDA for Revlon Rvsp3501 Spa Moisturestay Paraffin Bath (type Spb3752ea).
| Device ID | K093100 |
| 510k Number | K093100 |
| Device Name: | REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) |
| Classification | Bath, Paraffin |
| Applicant | SHENZHEN COMFORT TECHNOLOGY CO., LTD. 1705 S.CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Contact | Jean Asquith |
| Correspondent | Daniel Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | IMC |
| CFR Regulation Number | 890.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-10-01 |
| Decision Date | 2009-11-24 |
| Summary: | summary |