510(k) K811301
- Device
- TUBMATE
- Applicant
- AMERICAN STAIR-GLIDE CORP.
- 510(k) number
- K811301
- Product code
- ILS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-05-27
- Date received
- 1981-05-11
- 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#
- 3011669224
- 3016598690
- 3003123807
- 3038623066
- 3006400320
- 3021619631
- 3008603863
- 3017278503
- 3003947878
- 3019677893
- 3018514192
- 3017555752
- 3008386507
- 3015335961
- 3009694272
- 3043128491
- 3016678950
- 3023189540
- 3010394125
- 3004496806
- 3012316249
- 3004475699
- 3007120364
- 1000228440
- 3009703478
- 3004526603
- 3036893546
- 3006270986
- 3037012186
- 3031595580
- 2428983
- 3009420946
- 9618009
- 3004730072
- 3014523858
- 3015286905
- 3010287652
- 3021269058
- 8022890
- 3012821559
- 3031595778
- 3012579728
- 3043648106
- 3043749706
- 2084079
- 3010595915
- 3008386649
- 3009273990
- 3006803543
- 3010373530
- 3014204628
- 3017107376
- 3023272778
- 3030192580
- 3003770834
- 8022865
- 3009481053
- 3007499787
- 3004824601
- 3004126239
- 3043127556
- 3006984916
- 3007689746
- 3008388419
- 3001124136
- 3006795832
- 1523547
- 3007420694
- 3009952786
- 3033814356
- 3036978609
- 3029970239
- 3012271517
- 3027643666
- 3042276253
- 3009596133
- 3011251336
- 3029995169
- 1000206677
- 3021374638
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 |
Legacy Summary#
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FDA Review#
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