Patient Care Disposable Infant Shirts
FDA 510(k) K802998 · American Convertors Div., American Pharmaseal
510(k) numberK802998
Submission
- Device name
- Patient Care Disposable Infant Shirts
- Applicant
- American Convertors Div., American Pharmaseal
Mchenry, IL, US - Received
- November 25, 1980
- Decision date
- December 22, 1980
- 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 |
|---|---|---|
| K840957 | Antimicrobial Incise DrapeKKX · Traditional | 06/07/1984SE |
| K832137 | Convertors Flash Sterilizing TrayFSM · Traditional | 08/12/1983SE |
| K830786 | Disimetric Release of Instranetics RadKOA · Traditional | 05/18/1983SE |
| K820994 | Absorb Furn SheetFPY · Traditional | 05/13/1982SE |
| K813419 | Comfort Cushion Dry Burn Pad IIINAB · Traditional | 01/22/1982SE |
| K813296 | Convertors Sterile Disp. Lap Sponge IIEFQ · Traditional | 12/29/1981SE |
| K813078 | Contura Dispos. Surg. Face MaskFXX · Traditional | 12/18/1981SE |
| K812554 | Tomac Sterile Disp. Lap SpongeGDY · Traditional | 09/24/1981SE |
| K802919 | Iso-Bac Instrument WrapFRG · Traditional | 02/02/1981SE |
| K802359 | Disp. Fenestrated Surg. Drape SheetsKKX · Traditional | 10/31/1980SE |
Questions and answers
When was Patient Care Disposable Infant Shirts cleared by the FDA?
Patient Care Disposable Infant Shirts (K802998) received a 510(k) decision of Substantially Equivalent on December 22, 1980, 27 days after the submission was received.
What is the product code of K802998?
The FDA product code is KME – Bedding, Disposable, Medical, a Class I (low risk) device regulated under 21 CFR 880.6060.