510(k) K940468
- Device
- FEMININE MAXI PADS
- Applicant
- B.A. WHOLESALE, INC.
- 510(k) number
- K940468
- Product code
- HHD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-05-26
- Date received
- 1994-02-02
- Regulation
- 884.5435
- Classification name
- Pad, Menstrual, Unscented
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROLANDO GOMEZ
- Address
- 2465 E. Vernon Ave. Vernon CA US 90058 90058
FDA Registration Numbers#
- 3043127614
- 3045007242
- 3042370478
- 3016816754
- 3025349261
- 3008500638
- 3004134939
- 3016758972
- 3033920063
- 3018490537
- 3042193624
- 3021595883
- 3022540088
- 3006400113
- 3015972825
- 3009555608
- 3033535710
- 3017125176
- 3015379055
- 3005010990
- 3010287652
- 3014873189
- 3045978154
- 3008756267
- 3013450745
- 3004111573
- 3030516433
- 3029303082
- 3009673970
- 3006723122
- 3017248120
- 2648727
- 9613808
- 3017674087
- 3015729142
- 3038182652
- 3012097557
- 3008438232
- 3015391081
- 3013354376
- 3014268334
- 1043214
- 3013414322
- 3032172199
- 3026610069
- 1450743
- 3013511504
- 3015745793
- 3044876172
- 3033511100
- 3013865802
- 3043048216
- 3043603999
- 3027605322
- 3011862887
- 3007109658
- 3043152429
- 3016458366
- 3013235644
- 3015375647
- 3016702790
- 3005301318
- 3034669683
- 1648563
- 9710006
- 3012268821
- 9616088
- 3009046867
- 3016654531
- 3016733683
- 3026199504
- 3039282838
- 3012421607
- 3016640796
- 3013684440
- 3017021601
- 8043323
- 3014498545
- 3006710549
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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