Dispose-A-Sheet
FDA 510(k) K933636 · Belmac Healthcare Corp.
510(k) numberK933636
Submission
- Device name
- Dispose-A-Sheet
- Applicant
- Belmac Healthcare Corp.
Tampa, FL, US - Received
- July 27, 1993
- Decision date
- January 26, 1994
- 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 |
| 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 |
| K911950 | Medi Guard DrapesKME · Traditional | Sancella, Inc. | 05/21/1991SE |
Questions and answers
When was Dispose-A-Sheet cleared by the FDA?
Dispose-A-Sheet (K933636) received a 510(k) decision of Substantially Equivalent on January 26, 1994, 183 days after the submission was received.
What is the product code of K933636?
The FDA product code is KME – Bedding, Disposable, Medical, a Class I (low risk) device regulated under 21 CFR 880.6060.