DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST
FDA 510(k) clearance K902446 · decided 1990-08-10
Clearance details
- K-number
- K902446
- Device name
- DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST
- Applicant
- Mallinckrodt Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-06-01
- Decision date
- 1990-08-10
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- FMW
- Device class
- 1
- Regulation number
- 880.6190
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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| CORE PREVENT MATTRESS MODIFICATION (K935220) | Paladin Medical, Inc. | 1993-11-29 |
| REUSABLE INCONTIENT UNDERPAD (K924807) | Perfect Fit Industries, Inc. | 1993-02-10 |
| WIPEABLE PILLOW (K924477) | Perfect Fit Industries, Inc. | 1993-01-29 |
| OBALON COVER (K923173) | Turnsoft, Inc. | 1992-11-06 |
| SOFT-COVER (K921928) | Adroit Medical Systems, Inc. | 1992-11-06 |
| ALLERGY CONTROL COVERS (K903382) | Allergy Control Products, Inc. | 1990-11-02 |
| MATTRESS COVER, ANTI-MICROBIAL (K832483) | American Threshold Industries, Inc. | 1984-02-04 |
Recalls involving this device
No recalls on record reference this clearance.