Skin Saver Systems
FDA 510(k) K952738 · Skin Saver Systems, Inc.
510(k) numberK952738
Submission
- Device name
- Skin Saver Systems
- Applicant
- Skin Saver Systems, Inc.
Aurora, CO, US - Received
- June 14, 1995
- Decision date
- September 29, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FQM – Bandage, Elastic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5075
- Specialty
- General Hospital
Other 510(k)s with product code FQM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040936 | Petit Silma Elastic Bandage with Germanium/Titanium OxideFQM · Traditional | Leda Co., Ltd. | 05/03/2004SE |
| K040054 | Back in Action Compression & Support with Magnets for the Lower Back, Knee and AnkleFQM · Traditional | Theodore Barash | 04/27/2004SE |
| K013244 | Comfortcare Compression Support Witih Magnets and Aegis Microbe Shield Comfortcare…FQM · Traditional | Med Gen, Inc. | 12/07/2001SE |
| K872868 | Aspen Esmark BandageFQM · Traditional | Aspen Laboratories, Inc. | 07/31/1987SE |
| K840107 | Tube-Bandage for Human Digits 200FQM · Traditional | Zens Health Care Products | 04/25/1984SE |
| K831728 | MedicalexFQM · Traditional | Medicalex | 01/09/1984SE |
| K830622 | Ortho WrapFQM · Traditional | Fast Wrap Co., Inc. | 06/20/1983SE |
| K831551 | Compressogrip Tubular Elastic BandageFQM · Traditional | Fred Sammons, Inc. | 06/07/1983SE |
| K820142 | Tubular StockinetteFQM · Traditional | Stan-Pak Ent. | 02/05/1982SE |
| K820141 | Bias StockinetteFQM · Traditional | Stan-Pak Ent. | 02/05/1982SE |
Questions and answers
When was Skin Saver Systems cleared by the FDA?
Skin Saver Systems (K952738) received a 510(k) decision of Substantially Equivalent on September 29, 1995, 107 days after the submission was received.
What is the product code of K952738?
The FDA product code is FQM – Bandage, Elastic, a Class I (low risk) device regulated under 21 CFR 880.5075.