MEDI GUARD PILLOWCASE
FDA 510(k) clearance K911948 · decided 1991-05-28
Clearance details
- K-number
- K911948
- Device name
- MEDI GUARD PILLOWCASE
- Applicant
- Sancella, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-01
- Decision date
- 1991-05-28
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- KME
- Device class
- 1
- Regulation number
- 880.6060
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Canada, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| READY-HEAT BLANKET (K042145) | Techtrade, LLC | 2004-09-17 |
| OREX MEDICAL BEDDING (K944953) | Thantex Specialties, Inc. | 1994-12-02 |
| DISPOSE-A-SHEET (K933636) | Belmac Healthcare Corp. | 1994-01-26 |
| DOCTOR DOWN --RESCUE WRAP (K932539) | Three Dog Down | 1993-11-02 |
| AMERICAN BURN SHEET (K922143) | American Silk Sutures, Inc. | 1992-08-10 |
| FOIL BABY BUNTING (K915303) | Gam Industries, Inc. | 1992-02-20 |
| CHEM-SLEEVE B (K912257) | Haz-Med, Inc. | 1991-12-31 |
| MEDI GUARD UNDERPAD (K911952) | Sancella, Inc. | 1991-05-28 |
| MEDI GUARD SHEETS/UNDERLAYS (K911953) | Sancella, Inc. | 1991-05-28 |
| MEDI GUARD DRAPES (K911950) | Sancella, Inc. | 1991-05-21 |
| BIO-GUARD SHAVE PREP TRAY (K905003) | Network Medical Systems, Inc. | 1990-12-28 |
| RECEIVING BLANKET (K904274) | Anago, Inc. | 1990-10-26 |
Recalls involving this device
No recalls on record reference this clearance.