510(k) K761125
- Device
- Long Handled Sponge
- Applicant
- FRED SAMMONS, INC.
- 510(k) number
- K761125
- Product code
- ILS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-12-02
- Date received
- 1976-11-19
- 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#
- 3007791489
- 3011225385
- 3016678414
- 3015337373
- 1931307
- 3011310591
- 3010700223
- 3005720080
- 3003781173
- 3009273990
- 3003218744
- 9710117
- 3007120364
- 3009655869
- 3043654660
- 3033814356
- 3014172160
- 3031582440
- 1000206677
- 3005078659
- 3006897028
- 3001657382
- 3017555752
- 3006984916
- 2085249
- 3017278503
- 3009155756
- 3011706862
- 3003771601
- 3032171543
- 3007238754
- 3036978609
- 3030192580
- 3021966508
- 3006199389
- 3033881629
- 3010461764
- 3007481922
- 3014707731
- 3007309323
- 3004824601
- 3011191255
- 3009109991
- 3008467060
- 3008986539
- 3011475060
- 3007366413
- 3023272778
- 3032835495
- 3012468755
- 3023189540
- 3012821559
- 3015080575
- 3019677893
- 3009952786
- 3006068904
- 3030681105
- 3016170451
- 3015286905
- 3031583032
- 3008997160
- 3012706495
- 3008410069
- 3010603857
- 3016796135
- 3031595580
- 3023895623
- 3010373530
- 3033011342
- 3037012186
- 3009481053
- 3014146451
- 3036893546
- 3006619688
- 3032027168
- 3015526491
- 3014498763
- 3021327432
- 3001124136
- 3045030500
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 |