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#
- 3013875443
- 3001657382
- 3019502344
- 3030226293
- 3007218972
- 8022077
- 3016678414
- 3011225385
- 1062191
- 3013473968
- 3009567010
- 3004034546
- 3014146451
- 3015220328
- 3001124136
- 3015337373
- 3012468755
- 3011456684
- 3033881629
- 3027601985
- 3008555994
- 3010101089
- 3017181414
- 3021374638
- 9616091
- 3016734231
- 3031082325
- 3010700223
- 3005214422
- 3007019343
- 3008997160
- 3043105505
- 3038304894
- 3025369303
- 3003887292
- 3006270986
- 3009542966
- 3009211643
- 3029663088
- 3010603857
- 3016159374
- 3003781173
- 3034729907
- 3043654660
- 3024787345
- 3016847796
- 3011529559
- 3007366413
- 3008386507
- 3015526491
- 3033814356
- 3006984916
- 2085249
- 3004496806
- 3023272778
- 3008466086
- 3008685522
- 3045752480
- 3024946194
- 3019576863
- 3043460907
- 3025460026
- 3011251336
- 3010987649
- 1000206677
- 9681624
- 3010373530
- 2435707
- 3012327277
- 3010113803
- 3009155756
- 3014264913
- 3006553621
- 3006795832
- 3009273990
- 2084079
- 3015286905
- 3042276253
- 3010695559
- 3009420946
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 |