Multi-Trauma Dressing
FDA 510(k) K925590 · Gam Industries, Inc.
510(k) numberK925590
Submission
- Device name
- Multi-Trauma Dressing
- Applicant
- Gam Industries, Inc.
Petersburg, VA, US - Received
- November 5, 1992
- Decision date
- April 8, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NAB – Gauze / Sponge,Nonresorbable For External Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4014
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code NAB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K946015 | Ivalon External SpongeNAB · Traditional | Ivalon | 02/27/1995SE |
| K940755 | Isolyer (4X4, 8PLY)NAB · Traditional | Isolyer Co. | 05/02/1994SE |
| K931610 | Omnisorb II, Nonwoven Sponge, Sterile and NonNAB · Traditional | Omni Mfg., Inc. | 06/24/1993SE |
| K926072 | K-Band and K-CrepeNAB · Traditional | Parema , Ltd. | 03/19/1993SE |
| K915591 | Sterile Gauze PadsNAB · Traditional | Eagle Medical, Inc. | 01/27/1993SE |
| K924650 | Gauze SpongesNAB · Traditional | Dav-Mar Medical Products, Inc. | 01/11/1993SE |
| K923602 | Absorbent Pad -- ModificationNAB · Traditional | Winfield Laboratories, Inc. | 12/07/1992SE |
| K923115 | ClinisorbNAB · Traditional | Hermitage Hospital Products, Inc. | 11/23/1992SE |
| K923378 | Usp Type Vii Gauze SpongesNAB · Traditional | E.W.A., Ltd. | 10/06/1992SE |
| K923116 | Combine II Wetproof PadNAB · Traditional | Hermitage Hospital Products, Inc. | 10/06/1992SE |
More from Hermitage Hospital Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K941641 | Disposable Emergency Obstetrical KitKNA · Traditional | 10/03/1994SE |
| K941336 | Combo MaskKGB · Traditional | 09/09/1994SE |
| K942021 | Mouth to Mouth BreatherCBP · Traditional | 06/22/1994SE |
| K936050 | Jaw SpreaderKBW · Traditional | 03/24/1994SE |
| K930401 | Aluminum FoilMGP · Traditional | 05/12/1993SE |
| K926290 | Burn SheetFPY · Traditional | 04/20/1993SE |
| K915569 | Umbilical ClampHFW · Traditional | 09/23/1992SE |
| K915303 | Foil Baby BuntingKME · Traditional | 02/20/1992SE |
Questions and answers
When was Multi-Trauma Dressing cleared by the FDA?
Multi-Trauma Dressing (K925590) received a 510(k) decision of Substantially Equivalent on April 8, 1993, 154 days after the submission was received.
What is the product code of K925590?
The FDA product code is NAB – Gauze / Sponge,Nonresorbable For External Use, a Class I (low risk) device regulated under 21 CFR 878.4014.