HYGIENE ADAPTORS
FDA 510(k) clearance K810456 · decided 1981-03-04
Clearance details
- K-number
- K810456
- Device name
- HYGIENE ADAPTORS
- Applicant
- Fred Sammons, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-02-19
- Decision date
- 1981-03-04
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- ILS
- Device class
- 1
- Regulation number
- 890.5050
- 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 |
|---|---|---|
| MEDICAL TOILET SEAT (K852049) | Pedro Aleman | 1985-06-24 |
| COMMODE CHAIR 98200 (K842651) | Guardian Products Co., Inc. | 1984-08-07 |
| LAVATORY SEAT HEIGHTENER (K830853) | Lic-Orthion | 1983-06-08 |
| RAISED TOILET SEATS & NAIL CLIPPERS (K831547) | Fred Sammons, Inc. | 1983-06-08 |
| TOILET SEAT RAISED (K830425) | Maddak, Inc. | 1983-05-09 |
| SHOWER STOOL W/HANDLES (K830852) | Lic-Orthion | 1983-04-05 |
| BATHING CHAIR FOR CHILD (K823641) | Fred Sammons, Inc. | 1983-01-21 |
| DISPOSABLE TOOTH BRUSH (K823626) | Fred Sammons, Inc. | 1982-12-30 |
| PLASTIC BREAK RESISTANT MIRROR (K823606) | Fred Sammons, Inc. | 1982-12-28 |
| LAVATORY SEAT HEIGHTENER (K823155) | Orthion Corp. | 1982-11-05 |
| COLLAPSABLE LAVATORY HEIGHTENER (K823156) | Orthion Corp. | 1982-11-05 |
| BK-6477 THE DERBY RAISED TOILET SEAT (K821860) | Fred Sammons, Inc. | 1982-07-02 |
Recalls involving this device
No recalls on record reference this clearance.