510(k) K812352
- Device
- Hygiene Adaptors
- Applicant
- FRED SAMMONS, INC.
- 510(k) number
- K812352
- Product code
- ILS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-09-14
- Date received
- 1981-08-18
- Regulation
- 890.5050
- Classification name
- Adaptor, Hygiene
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3008986539
- 3043648106
- 3007082185
- 3009407891
- 3014498763
- 3010287652
- 3013823570
- 3030539818
- 3009425497
- 3003887292
- 3016734231
- 3015775924
- 3017607477
- 3007499787
- 3010729057
- 3012468755
- 3042278063
- 3009542966
- 3021167963
- 3009655869
- 3016598690
- 3008009450
- 3031595580
- 3007366413
- 3007802293
- 3008311431
- 3003775119
- 3003123807
- 3007420694
- 3019576863
- 3012316249
- 3011251336
- 3019505063
- 3026875457
- 3009683397
- 3015286905
- 3012327277
- 3005214422
- 3004194020
- 3014707731
- 3010147274
- 3011456684
- 3008485769
- 3008466086
- 3017278503
- 3009273990
- 3030504647
- 3013463240
- 3004034546
- 8022890
- 3016426850
- 3016678414
- 3013600135
- 3008685522
- 2128677
- 3023895623
- 3043127556
- 9616091
- 3007222468
- 3010394125
- 3016796135
- 9611956
- 3011669224
- 3006537699
- 3016968725
- 3006199389
- 3007160937
- 3043105505
- 3012821559
- 9618009
- 3013514644
- 3031284260
- 3043460907
- 3015989868
- 3009481053
- 3004496806
- 3015080575
- 3018514192
- 3012579728
- 3023395601
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ILS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K852049 | MEDICAL TOILET SEAT | Pedro Aleman | 1985-06-24 |
| K842651 | COMMODE CHAIR 98200 | Guardian Products Co., Inc. | 1984-08-07 |
| K830853 | LAVATORY SEAT HEIGHTENER | Lic-Orthion | 1983-06-08 |
| K831547 | RAISED TOILET SEATS & NAIL CLIPPERS | Fred Sammons, Inc. | 1983-06-08 |
| K830425 | TOILET SEAT RAISED | Maddak, Inc. | 1983-05-09 |
| K830852 | SHOWER STOOL W/HANDLES | Lic-Orthion | 1983-04-05 |
| K823641 | BATHING CHAIR FOR CHILD | Fred Sammons, Inc. | 1983-01-21 |
| K823626 | DISPOSABLE TOOTH BRUSH | Fred Sammons, Inc. | 1982-12-30 |
| K823606 | PLASTIC BREAK RESISTANT MIRROR | Fred Sammons, Inc. | 1982-12-28 |
| K823155 | LAVATORY SEAT HEIGHTENER | Orthion Corp. | 1982-11-05 |
| K823156 | COLLAPSABLE LAVATORY HEIGHTENER | Orthion Corp. | 1982-11-05 |
| K821860 | BK-6477 THE DERBY RAISED TOILET SEAT | Fred Sammons, Inc. | 1982-07-02 |
| K821638 | HYGIENE ADAPTORS | Fred Sammons, Inc. | 1982-06-11 |
| K821009 | BATHTUB GRAB BAR | Guardian Products Co., Inc. | 1982-04-21 |
| K813635 | CHILDS TOILET TRAINER HYGIENE AIDS | Fred Sammons, Inc. | 1982-01-19 |