Attends Dispos. Underpad
FDA 510(k) K853880 · Procter & Gamble Mfg. Co.
510(k) numberK853880
Submission
- Device name
- Attends Dispos. Underpad
- Applicant
- Procter & Gamble Mfg. Co.
Cincinnati, OH, US - Received
- September 18, 1985
- Decision date
- October 16, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K915303 | Foil Baby BuntingKME · Traditional | Gam Industries, Inc. | 02/20/1992SE |
| 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 |
More from Sancella, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873457 | Scented or Scented Deodorized Menstrual PadsHIL · Traditional | 01/19/1988SE |
| K873036 | Attends Incontinent BriefEYQ · Traditional | 01/19/1988SE |
| K864673 | Unscented Menstrual PadHHL · Traditional | 01/21/1987SE |
| K861863 | Modified Protective GarmentEYQ · Traditional | 08/11/1986SE |
| K862348 | Single-Use Patient UnderpadKME · Traditional | 07/02/1986SE |
| K860598 | Modified Protective Garment for IncontinentsEYQ · Traditional | 03/05/1986SE |
| K853000 | Scented Always PantilinersHHL · Traditional | 09/06/1985SE |
| K852985 | Unscented Always PantilinersHHD · Traditional | 08/29/1985SE |
| K850956 | Always Maxipads - ScentedHHL · Traditional | 05/14/1985SE |
| K850955 | Always Maxipads - UnscentedHHD · Traditional | 05/14/1985SE |
Questions and answers
When was Attends Dispos. Underpad cleared by the FDA?
Attends Dispos. Underpad (K853880) received a 510(k) decision of Substantially Equivalent on October 16, 1985, 28 days after the submission was received.
What is the product code of K853880?
The FDA product code is KME – Bedding, Disposable, Medical, a Class I (low risk) device regulated under 21 CFR 880.6060.