KME — Bedding, Disposable, Medical Class I
FDA product code KME covers "Bedding, Disposable, Medical", a Class I medical device regulated under 21 CFR 880.6060. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KME
- Device Class
- Class I
- Regulation Number
- 880.6060
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K042145 | techtrade | READY-HEAT BLANKET | September 17, 2004 |
| K944953 | thantex specialties | OREX MEDICAL BEDDING | December 2, 1994 |
| K933636 | belmac healthcare | DISPOSE-A-SHEET | January 26, 1994 |
| K932539 | three dog down | DOCTOR DOWN --RESCUE WRAP | November 2, 1993 |
| K922143 | american silk sutures | AMERICAN BURN SHEET | August 10, 1992 |
| K915303 | gam industries | FOIL BABY BUNTING | February 20, 1992 |
| K912257 | haz-med | CHEM-SLEEVE B | December 31, 1991 |
| K911952 | sancella | MEDI GUARD UNDERPAD | May 28, 1991 |
| K911948 | sancella | MEDI GUARD PILLOWCASE | May 28, 1991 |
| K911953 | sancella | MEDI GUARD SHEETS/UNDERLAYS | May 28, 1991 |
| K911950 | sancella | MEDI GUARD DRAPES | May 21, 1991 |
| K905003 | network medical systems | BIO-GUARD SHAVE PREP TRAY | December 28, 1990 |
| K904274 | anago | RECEIVING BLANKET | October 26, 1990 |
| K901509 | haz-med | TRAUMA SLEEVE | September 12, 1990 |
| K901629 | haz-med | CHEM-SLEEVE | April 27, 1990 |
| K900643 | infection control products | FLUID SOAKERSHIELD | April 25, 1990 |
| K896043 | keystone veterinary supplies | MATTRESS COVER FOR MEDICAL PURPOSES | January 10, 1990 |
| K891986 | mark one healthcare products | MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE | December 29, 1989 |
| K894170 | devon industries | DEVON DISPOSABLE HEAD POSITIONER COVER | September 7, 1989 |
| K884380 | saybrex intl | BED SHEET, PILLOW CASE | November 8, 1988 |