Foil Baby Bunting
FDA 510(k) K915303 · Gam Industries, Inc.
510(k) numberK915303
Submission
- Device name
- Foil Baby Bunting
- Applicant
- Gam Industries, Inc.
Petersburg, VA, US - Received
- November 21, 1991
- Decision date
- February 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KME – Bedding, Disposable, Medical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6060
- Specialty
- General Hospital
Other 510(k)s with product code KME
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042145 | Ready-Heat BlanketKME · Traditional | Techtrade, LLC | 09/17/2004SE |
| K944953 | Orex Medical BeddingKME · Traditional | Thantex Specialties, Inc. | 12/02/1994SE |
| K933636 | Dispose-A-SheetKME · Traditional | Belmac Healthcare Corp. | 01/26/1994SE |
| K932539 | Doctor Down --Rescue WrapKME · Traditional | Three Dog Down | 11/02/1993SE |
| K922143 | American Burn SheetKME · Traditional | American Silk Sutures, Inc. | 08/10/1992SE |
| K912257 | Chem-Sleeve BKME · Traditional | Haz-Med, Inc. | 12/31/1991SE |
| K911953 | Medi Guard Sheets/UnderlaysKME · Traditional | Sancella, Inc. | 05/28/1991SE |
| K911952 | Medi Guard UnderpadKME · Traditional | Sancella, Inc. | 05/28/1991SE |
| K911948 | Medi Guard PillowcaseKME · Traditional | Sancella, Inc. | 05/28/1991SE |
| K911950 | Medi Guard DrapesKME · Traditional | Sancella, Inc. | 05/21/1991SE |
More from Sancella, 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 |
| K925590 | Multi-Trauma DressingNAB · Traditional | 04/08/1993SE |
| K915569 | Umbilical ClampHFW · Traditional | 09/23/1992SE |
Questions and answers
When was Foil Baby Bunting cleared by the FDA?
Foil Baby Bunting (K915303) received a 510(k) decision of Substantially Equivalent on February 20, 1992, 91 days after the submission was received.
What is the product code of K915303?
The FDA product code is KME – Bedding, Disposable, Medical, a Class I (low risk) device regulated under 21 CFR 880.6060.