The following data is part of a premarket notification filed by Dermatech Medical Inc with the FDA for Dermatech Iv Holder.
| Device ID | K060488 |
| 510k Number | K060488 |
| Device Name: | DERMATECH IV HOLDER |
| Classification | Set, Administration, Intravascular |
| Applicant | DERMATECH MEDICAL INC 102 HERITAGE AVE Castle Rock, CO 80104 |
| Contact | Glenn Thibault |
| Correspondent | Glenn Thibault DERMATECH MEDICAL INC 102 HERITAGE AVE Castle Rock, CO 80104 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-24 |
| Decision Date | 2006-06-08 |
| Summary: | summary |