510(k) K905178
- Device
- DELUXE SANITARY PAD
- Applicant
- AMERICAN HEALTHCARE CORP.
- 510(k) number
- K905178
- Product code
- HHD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-03-04
- Date received
- 1990-11-19
- 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#
- Contact
- CAROL MASON
- Address
- 30 Craig St. Brantford, Ontario N3t 5m9 Canada CA
FDA Registration Numbers#
- 3017417656
- 3042277215
- 3004111573
- 3039357921
- 1648563
- 3013354376
- 3013526605
- 3042943260
- 3016758972
- 8022168
- 3016457665
- 3010486573
- 3030671612
- 3013521223
- 3016860525
- 3031481008
- 8043647
- 3016671078
- 3015136704
- 3026199504
- 3025306492
- 3005172118
- 3006704694
- 3040336235
- 3008951115
- 3003449633
- 3042193624
- 3038220293
- 3039394934
- 3016995285
- 3045924479
- 3012237070
- 3033849664
- 3004134939
- 3005613390
- 3003449471
- 1055236
- 3005301318
- 2515444
- 3004402508
- 3013479058
- 1319302
- 3010418793
- 3004443383
- 3016126870
- 3033527721
- 3013865802
- 3033535710
- 3034669683
- 1423537
- 3017125176
- 3007073647
- 3004950768
- 3006073016
- 3038182652
- 3044876172
- 3036679730
- 3015972825
- 3008808082
- 3013445151
- 2184163
- 3011109575
- 3016733683
- 3016816754
- 3032370
- 3016640796
- 3012409274
- 3006400076
- 3042370478
- 3016171962
- 3008044472
- 3017674087
- 3016768955
- 3007340125
- 3008896967
- 3033952011
- 3045007242
- 2320762
- 3005078659
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases