510(k) K812333
- Device
- CYCLES REUSABLE MENSTRUAL PADS
- Applicant
- CYCLES
- 510(k) number
- K812333
- Product code
- HHD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-09-08
- Date received
- 1981-08-18
- Regulation
- 884.5435
- Classification name
- Pad, Menstrual, Unscented
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- 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#
- 3016756928
- 3016749984
- 3039357921
- 3004585750
- 3025306492
- 3004443383
- 3007696018
- 3006073016
- 3016768955
- 3009555608
- 3014128751
- 3014205191
- 3016702790
- 3027436335
- 3030530728
- 3019735068
- 3026610069
- 3033848221
- 3026858378
- 3005010990
- 3011446173
- 3015439973
- 3035857757
- 3033891285
- 3013880493
- 9615496
- 3003701733
- 3004134939
- 3012934891
- 3008756267
- 3007838093
- 9617256
- 1041732
- 3011964664
- 3003449471
- 3006517653
- 3025360957
- 3016010004
- 9710006
- 3030516298
- 3014631422
- 3011746259
- 3043153496
- 3017654286
- 3013865802
- 9613808
- 3006227741
- 3042277215
- 3044882452
- 3005078659
- 3017021601
- 3030469775
- 3030187570
- 3005630901
- 8022168
- 3043126871
- 3015745793
- 3008929712
- 3006479639
- 3010402957
- 1417592
- 3013521223
- 3015729142
- 3015913483
- 3012391162
- 3040336235
- 3010692191
- 3012421607
- 1061124
- 1055236
- 3015009203
- 3004111573
- 3011360380
- 3010287652
- 3010183315
- 3017125176
- 3016860525
- 3033511100
- 3011151836
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HHD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K071827 | ALWAYS MENSTRUAL PADS | Procter & Gamble, Inc. | 2007-09-20 |
| K012629 | ALWAYS DUETS | Procter & Gamble Co. | 2001-10-05 |
| K003843 | ENVIVE MINIFORMS | Procter & Gamble Co. | 2001-02-08 |
| K993870 | UNSCENTED INTERLABIAL MENSTRUAL PAD | Procter & Gamble Co. | 2000-01-18 |
| K980395 | GLADRAGS COTTON MENSTRUAL PAD | Keepers!, Inc. | 1998-04-16 |
| K953470 | FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS) | Mediquip, Inc. | 1995-11-21 |
| K953633 | UNSCENTED MENSTRUAL PAD | Tendasoft, Inc. | 1995-11-01 |
| K953667 | UNSCENTED CURVED ULTRATHIN MAXI PADS | Paragon Trade Brands, Inc. | 1995-11-01 |
| K953668 | UNSCENTED ULTRATHIN MAXI PAD | Paragon Trade Brands, Inc. | 1995-11-01 |
| K953553 | UNSCENTED MENSTRAL PAD | Paragon Trade Brands, Inc. | 1995-10-27 |
| K953517 | UNSCENTED MENSTRUAL PAD | Paragon Trade Brands, Inc. | 1995-10-26 |
| K953666 | UNSCENTED MENSTRAL PAD WITH WINGS | Paragon Trade Brands, Inc. | 1995-09-27 |
| K953700 | UNSCENTED CURVED MAXI PAD | Paragon Trade Brands, Inc. | 1995-09-27 |
| K953487 | UNSCENTED MENSTRUAL SHIELD | Paragon Trade Brands, Inc. | 1995-08-09 |
| K953488 | UNSCENTED MENSTRUAL LINER | Paragon Trade Brands, Inc. | 1995-08-09 |
Legacy Summary#
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FDA Review#
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