Interdry Silver
FDA 510(k) K110715 · Milliken Healthcare Products, LLC
510(k) numberK110715
Submission
- Device name
- Interdry Silver
- Applicant
- Milliken Healthcare Products, LLC
Spartanburg, SC, US - Received
- March 15, 2011
- Decision date
- November 4, 2011
- 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 |
| K061615 | Interdry Textile with SilverFRL · Traditional | Milliken Chemical | 12/22/2006SE |
| 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.
Questions and answers
When was Interdry Silver cleared by the FDA?
Interdry Silver (K110715) received a 510(k) decision of Substantially Equivalent on November 4, 2011, 234 days after the submission was received.
What is the product code of K110715?
The FDA product code is FRL – Fiber, Medical, Absorbent, a Class I (low risk) device regulated under 21 CFR 880.5300.