510(k) K971303
- Device
- INSTEAD, SOFTCUP
- Applicant
- ULTRAFEM, INC.
- 510(k) number
- K971303
- Product code
- HHE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-06-06
- Date received
- 1997-04-08
- Regulation
- 884.5400
- Classification name
- Cup, Menstrual
- 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
- PETER S REICHERTZ
- Address
- 1050 Connecticut Ave., NW Washington DC US 20036 20036
FDA Registration Numbers#
- 3022568093
- 3023054050
- 3014316197
- 3009086335
- 3027115741
- 3030516433
- 3038008627
- 9710567
- 3011390138
- 3006517653
- 3016195105
- 3016733683
- 3016702790
- 3017978050
- 3014437893
- 3011964664
- 3043048216
- 3011986317
- 3043475715
- 3013865802
- 3003270419
- 3013445151
- 3018188559
- 3012477715
- 3013581854
- 3014829931
- 3011296497
- 3007962592
- 3015422018
- 3016171962
- 3009881291
- 2031897
- 3013496867
- 3005246636
- 3014926189
- 3014686987
- 3008500638
- 3013354376
- 3013509097
- 3038293079
- 3016763307
- 3012930455
- 3017889736
- 3006317264
- 3017866897
- 3026986849
- 3025112778
- 3016567447
- 3012097557
- 3014383580
- 8022032
- 3012684779
- 2025182
- 3003882387
- 3016421238
- 3018783049
- 3012971814
- 3017299798
- 3006899153
- 9680411
- 3038641388
- 3013674629
- 3013427445
- 3021340005
- 3005113602
- 1523399
- 3018179390
- 3011660924
- 3014329589
- 3006479639
- 3004123648
- 3012074930
- 3013909820
- 3010965020
- 3042276479
- 3009803802
- 3013478062
- 3014276660
- 3010964133
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HHE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233361 | Sunny Cup and Applicator | Menstrual Mates | 2024-06-21 |
| K140626 | MELUNA CLASSIC/SPORT MENSTRUAL CUP | Meluna | 2014-07-10 |
| K121857 | FEMMYCYCLE | Femcap Incorporated | 2012-11-15 |
| K120107 | SCKOONCUP | Sckoon, Inc. | 2012-09-18 |
| K112165 | RHEA CUP | Apex Medical Technologies, Inc. | 2012-05-24 |
| K092985 | BELLECUP | Librette, Inc. | 2010-06-28 |
| K091754 | LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 | Lune Group , Ltd. | 2009-11-13 |
| K070965 | ALICIA MENSTRUAL CUP | Alicia International Pty , Ltd. | 2008-03-05 |
| K060852 | MOONCUP | Mooncup Limited | 2006-12-26 |
| K040335 | MOONCUP, STYLE A & B | Mooncup, LLC | 2005-03-30 |
| K021356 | THE DIVACUP MENSTRUAL SOLUTION | Diva International, Inc. | 2002-07-16 |
| K920792 | SOFTCUP(TM):2 | Ultrafem, Inc. | 1993-10-05 |
| K910254 | DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) | CooperSurgical, Inc. | 1991-04-18 |
| K870803 | THE KEEPER | The Keeper Co. | 1987-05-06 |
| K803250 | TASSAWAY | Plastic Applications, Inc. | 1981-02-12 |
Legacy Summary#
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FDA Review#
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