The following data is part of a premarket notification filed by Escada International, Inc. with the FDA for Terraquant Mq2000 V. 5 And Handyrx Mq2007 Lasers.
| Device ID | K061614 |
| 510k Number | K061614 |
| Device Name: | TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-09 |
| Decision Date | 2006-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852556007169 | K061614 | 000 |
| 00852556007145 | K061614 | 000 |
| 00852556007121 | K061614 | 000 |
| 00852556007114 | K061614 | 000 |
| 00852556007084 | K061614 | 000 |