510(k) K950194
- Device
- TAMPON, UNTREATED
- Applicant
- HYGIEIA HEALTHCARE LTD.
- 510(k) number
- K950194
- Product code
- HEB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-08-25
- Date received
- 1995-01-18
- Regulation
- 884.5470
- Classification name
- Tampon, Menstrual, Unscented
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- P BRENIKOV
- Address
- Unit 2 Sunrise Enterprise Park Ferryboat Ln. Castletown, Sunderland Sr5 3rx GB SR5 3RX SR5 3RX
FDA Registration Numbers#
- 8043647
- 3014829931
- 9615100
- 3010418793
- 3027520366
- 3011050481
- 3006479639
- 3042370478
- 3006073016
- 3030516298
- 3012133441
- 3015271338
- 3036679730
- 3026199504
- 3013235644
- 3007838093
- 3010749695
- 3003500682
- 3017125080
- 9710006
- 1651897
- 1219109
- 8043323
- 3026610069
- 3014193134
- 3004069780
- 3003559457
- 3038182652
- 3022076670
- 3012097557
- 3030979401
- 1000136042
- 3011964664
- 3012934891
- 3012117640
- 3011109575
- 3017654286
- 3021389492
- 1648563
- 1226146
- 1523399
- 3006517653
- 3013445151
- 3004443383
- 1000219986
- 3043603999
- 3043534331
- 3043048216
- 3008381943
- 3006241352
- 3017025817
- 3024787082
- 3013865802
- 3009470597
- 3013298431
- 3030234187
- 2515444
- 3016010004
- 3030019161
- 3015391081
- 3007740671
- 2938651
- 3006015326
- 3017125176
- 3030534974
- 9613295
- 3010692191
- 3015259875
- 3044091160
- 3014833751
- 3014128751
- 3012736230
- 3015375647
- 3008925277
- 3019735068
- 3028725772
- 3015522042
- 3012118920
- 3004402508
- 3013354376
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HEB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252005 | Livi Device | Liviwell, Inc. | 2026-03-20 |
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. | 2025-12-17 |
| K252939 | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS | Cotton High Tech S.L. | 2025-10-09 |
| K252613 | Unscented menstrual three-piece applicator tampon | Unibeauty (Hubei) Technology Co., Ltd. | 2025-09-19 |
| K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. | 2025-08-13 |
| K242105 | SABA Tampons | Essity Higiene Y Salud Mexico. S.A. DE C.V. | 2025-04-01 |
| K241064 | Unscented Tampon | Shandong Intco Hygiene Products Co., Ltd. | 2025-01-10 |
| K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord Tampon | Suzhou Borage Medical Technology Co., Ltd. | 2024-05-10 |
| K232060 | TOSAMA Reusable Applicator | Tosama, D.O.O. | 2024-04-12 |
| K232598 | Unscented Menstrual Tampon | Unibeauty (Hubei) Technology Co., Ltd. | 2023-12-15 |
| K223883 | Daye Tampon | Annes Daye, Ltd. | 2023-08-18 |
| K231341 | Organic cotton tampon, Viscose tampon | Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | 2023-08-14 |
| K230419 | Sequel Tampon with Plastic Applicator | Tampro, Inc. | 2023-08-03 |
| K223749 | U by Kotex® Click® Unscented Menstrual Tampons | Kimberly-Clark Corporation | 2023-01-06 |
| K222046 | Unscented Menstrual Tampon | Suzhou Borage Medical Technology Co., Ltd. | 2022-09-30 |
Legacy Summary#
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FDA Review#
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