The following data is part of a premarket notification filed by Milliken Chemical with the FDA for Interdry Textile With Silver.
Device ID | K061615 |
510k Number | K061615 |
Device Name: | INTERDRY TEXTILE WITH SILVER |
Classification | Fiber, Medical, Absorbent |
Applicant | MILLIKEN CHEMICAL 49 PLAIN STREET North Attleboro, MA 02760 |
Contact | Mary Mcnamara-cullinane |
Correspondent | Mary Mcnamara-cullinane MILLIKEN CHEMICAL 49 PLAIN STREET North Attleboro, MA 02760 |
Product Code | FRL |
CFR Regulation Number | 880.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-09 |
Decision Date | 2006-12-22 |
Summary: | summary |