The following data is part of a premarket notification filed by Escada International, Inc. with the FDA for Terraquant Mq2000 Laser Therapy Device.
| Device ID | K043055 |
| 510k Number | K043055 |
| Device Name: | TERRAQUANT MQ2000 LASER THERAPY DEVICE |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | ESCADA INTERNATIONAL, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane ESCADA INTERNATIONAL, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-05 |
| Decision Date | 2005-07-25 |
| Summary: | summary |