MAC LEE SITZ BATH
FDA 510(k) clearance K841711 · decided 1984-05-07
Clearance details
- K-number
- K841711
- Device name
- MAC LEE SITZ BATH
- Applicant
- Mac Lee Medical Products
- Decision
- Substantially Equivalent
- Date received
- 1984-04-24
- Decision date
- 1984-05-07
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- KTC
- Device class
- 1
- Regulation number
- 890.5125
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- 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 |
|---|---|---|
| THE SPRITZ BATH (K912179) | The Spritz Co. | 1991-08-28 |
| SIT-N-BATHE SITZ BATH (K890085) | Drummond Industries, Inc. | 1989-02-13 |
| SITZ BATH (K862600) | W. C. Green, D.D.S. | 1986-07-18 |
| ABCO PLASTIC UTENSILS (K851309) | Abco Dealers, Inc. | 1985-07-01 |
| SITZ BATH, SINGLE PATIENT USE #8100 (K831762) | Lsl Industries, Inc. | 1983-06-24 |
| PERSONAL SITZ BATH KIT (K800958) | The Healthcare Group Laboratories, Inc. | 1980-05-02 |
Recalls involving this device
No recalls on record reference this clearance.