510(k) K823606
- Device
- PLASTIC BREAK RESISTANT MIRROR
- Applicant
- FRED SAMMONS, INC.
- 510(k) number
- K823606
- Product code
- ILS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-12-28
- Date received
- 1982-12-06
- 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#
- 3042276253
- 2937137
- 3015337373
- 3007160937
- 8022865
- 3009420946
- 3016159374
- 3013495708
- 3016598690
- 3004024088
- 3010729057
- 3016796135
- 3014498763
- 3017607477
- 3013545943
- 3017079526
- 3030539818
- 3038304894
- 3005720080
- 3009109991
- 3043648106
- 3036893546
- 3005555653
- 3036978609
- 9616091
- 3017155124
- 3011310591
- 3029970239
- 3045030500
- 3030681105
- 3014268398
- 3023272778
- 3006553621
- 3007309323
- 3008986539
- 3005651859
- 3015286905
- 3019576863
- 3003775119
- 3008352964
- 3004475699
- 3015526491
- 3035743951
- 8022755
- 9611956
- 3005214422
- 3024088964
- 3017107376
- 3008466086
- 3029995169
- 3043126945
- 3014204628
- 3007515312
- 3032835495
- 3006400320
- 3006068904
- 3013473968
- 3008685522
- 3004034546
- 3006619688
- 3025369303
- 3025460026
- 3032027168
- 3010394125
- 3016170451
- 3009327812
- 1062191
- 3010220187
- 3003770834
- 3043479340
- 3045058049
- 3007366413
- 3003218744
- 3007218972
- 9618009
- 3010875172
- 3016678950
- 1313700
- 3010603857
- 3026875457
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 |
| 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 |
| K812352 | HYGIENE ADAPTORS | Fred Sammons, Inc. | 1981-09-14 |
Legacy Summary#
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FDA Review#
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