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 |