510(k) K843544
- Device
- THE BIBICURE SYS BREAST TONER
- Applicant
- Les Entreprises Bibi, Inc.
- 510(k) number
- K843544
- Product code
- HGY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-01-25
- Date received
- 1984-09-07
- Regulation
- 884.5150
- Classification name
- Pump, Breast, Non-Powered
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PIA DAMTSIS
- Address
- 55 Louvain Auest Suite 418 Quebec Montreal H2n1a4 CA
FDA Registration Numbers#
- 1123137
- 3012298445
- 3024790242
- 3009826814
- 3002857192
- 3016562061
- 3016746538
- 3009243271
- 1419937
- 3013699454
- 3000126629
- 8010730
- 3006131984
- 3031580411
- 3029906449
- 3012062596
- 2381321
- 3039358595
- 3006157842
- 3005630901
- 3010332886
- 1000634183
- 3029994331
- 3010359222
- 3008478778
- 3013053058
- 3027371585
- 3003965134
- 3006774448
- 3004957421
- 3017618900
- 1928237
- 3012759464
- 3000215556
- 3027605322
- 3003697955
- 3025376765
- 3009109684
- 3012605672
- 3005327291
- 3030479957
- 1217805
- 3010337881
- 3009124884
- 3006787036
- 3016915446
- 3020998419
- 3026848699
- 3026986849
- 3017816623
- 1417592
- 1424785
- 3015277913
- 3005031124
- 3031566471
- 3027841329
- 3018130625
- 3006610790
- 3013561139
- 3008045828
- 3012684779
- 3020994856
- 3008729914
- 3014759586
- 3009700166
- 3025360194
- 3010334650
- 3030158784
- 3011139154
- 1721686
- 9680411
- 3015526174
- 3026324262
- 3008687634
- 2025917
- 9710641
- 3010822231
- 3003509351
- 3008957271
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HGY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K101538 | HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) | Philips Electronics UK Limited | 2010-11-05 |
| K032845 | EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 | The First Years, Inc. | 2004-04-05 |
| K013226 | EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT | Evenflo Company, Inc. | 2001-12-20 |
| K011519 | AMEDA HYGIENIKIT | Hollister, Inc. | 2001-08-15 |
| K971231 | WHITE RIVER MINI MANUAL BREAST PUMP | White River Concepts | 1997-05-19 |
| K962828 | EVERT-IT | Genesis Industries, Inc. | 1997-02-10 |
| K952034 | MEDELA'S FOOT PUMP | Medela, Inc. | 1995-09-12 |
| K952035 | NIPLETTE | Avent America, Inc. | 1995-07-28 |
| K925738 | WHITE RIVER MANUAL BREAST PUMP | White River (Tm) | 1994-05-04 |
| K912355 | MOTHERS TOUCH ONE HAND BREAST PUMP | Hollister, Inc. | 1993-12-10 |
| K902552 | GERBER PRECIOUS CARE ELECTRIC BREAST PUMP | Gerber Products Co. | 1990-09-26 |
| K844297 | SUPPLEMENTAL FEEDING SYSTEM | Medela, Inc. | 1985-02-25 |
| K850242 | CRYSTAL MANUAL BREAST PUMP | Crystal Medical Products, Inc. | 1985-02-25 |
| K840874 | RODY BREAST PUMP | Kean-Rody Manufacturer | 1984-07-23 |
| K840325 | INFA COMPLETE BREAST PUMP & MILK STORAG | Monterey Laboratories, Inc. | 1984-03-05 |