Interdry Textile with Silver
FDA 510(k) K061615 · Milliken Chemical
510(k) numberK061615
Submission
- Device name
- Interdry Textile with Silver
- Applicant
- Milliken Chemical
North Attleboro, MA, US - Received
- June 9, 2006
- Decision date
- December 22, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRL – Fiber, Medical, Absorbent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5300
- Specialty
- General Hospital
Other 510(k)s with product code FRL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121898 | Stay Fresh Skin Fold Management TextileFRL · Traditional | Quick-Med Technologies, Inc. | 05/24/2013SE |
| K110715 | Interdry SilverFRL · Traditional | Milliken Healthcare Products, LLC | 11/04/2011SE |
| K931626 | Carapace Sterile Cotton BallsFRL · Traditional | Carapace, Inc. | 12/02/1993SE |
| K914081 | Ican Cotton Rayon BallsFRL · Traditional | Icn Pharmaceuticals, Inc. | 10/09/1991SE |
| K811990 | Trach Cleaning TrayFRL · Traditional | Associated Medical Products Co. | 07/27/1981SE |
| K810242 | Utensil & Procedure TraysFRL · Traditional | American Hospital Supply Corp. | 04/15/1981SE |
| K800277 | Medspec Rayon BallsFRL · Traditional | Medspec Corp. | 03/12/1980SE |
| K800249 | Surgitek Foerster Mammary BandageFRL · Traditional | Medical Engineering Corp. | 02/19/1980SE |
| K800248 | Surgitek Foerster Face Lift BandageFRL · Traditional | Medical Engineering Corp. | 02/19/1980SE |
| K792295 | SorbiesFRL · Traditional | American Hospital Supply Corp. | 12/20/1979SE |
More from American Hospital Supply Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K051445 | Milliken Silver Wound DressingsFRO · Traditional | 08/22/2005SE |
Questions and answers
When was Interdry Textile with Silver cleared by the FDA?
Interdry Textile with Silver (K061615) received a 510(k) decision of Substantially Equivalent on December 22, 2006, 196 days after the submission was received.
What is the product code of K061615?
The FDA product code is FRL – Fiber, Medical, Absorbent, a Class I (low risk) device regulated under 21 CFR 880.5300.