The following data is part of a premarket notification filed by Juniper Medical Technology, Inc with the FDA for Juniper Cooling Device.
| Device ID | K060407 |
| 510k Number | K060407 |
| Device Name: | JUNIPER COOLING DEVICE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | JUNIPER MEDICAL TECHNOLOGY, INC 7139 KOLL PARKWAY SUITE 300 Pleasanton, CA 94566 |
| Contact | Rosemary Harry |
| Correspondent | Rosemary Harry JUNIPER MEDICAL TECHNOLOGY, INC 7139 KOLL PARKWAY SUITE 300 Pleasanton, CA 94566 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-16 |
| Decision Date | 2006-05-31 |
| Summary: | summary |