510(k) K904160
- Device
- CYTOSMEAR BRUSH
- Applicant
- BROOKE INTL.
- 510(k) number
- K904160
- Product code
- HHI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-11-02
- Date received
- 1990-09-11
- Regulation
- 884.5070
- Classification name
- System, Abortion, Vacuum
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- TODD M GATES
- Address
- 3555 Landfair Rd. Pasadena CA US 91107 91107
FDA Registration Numbers#
- 3013557562
- 9680254
- 9710641
- 9611102
- 3014615028
- 3006131984
- 3043226252
- 3011050570
- 1450908
- 2029275
- 1424263
- 8044099
- 3004111573
- 3012494290
- 1422634
- 3008007615
- 2953359
- 3005273623
- 1519132
- 3003790304
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HHI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171440 | Berkeley VC-10 Vacuum Curettage System | Gyrus Acmi | 2017-09-29 |
| K030935 | BERKELEY V-10 VACUUM CURETTAGE SYSTEM | Acmi Corporation | 2003-06-23 |
| K983181 | CYTOPREP | Cytoprep Inc. Est. | 1998-11-16 |
| K931205 | MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER | Baxter Healthcare Corp | 1994-03-15 |
| K900641 | CANNULA, SUCTION UTERINE | Williams Specialty Products, Inc. | 1990-03-30 |
| K900642 | SWIVEL ADAPTER | Williams Specialty Products, Inc. | 1990-03-19 |
| K880734 | SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS | Personal Products Co. | 1988-04-25 |
| K873552 | CANNULA AND GENERAL PURPOSE ASPIRATOR | Cosmedtech, Inc. | 1987-11-25 |
| K870574 | COSMEDTECH GENERAL ASPIRATOR | Cosmedtech, Inc. | 1987-03-05 |
| K870560 | COSMEDTECH CANNULA | Cosmedtech, Inc. | 1987-03-04 |
| K862476 | LS3000 CANNULA UTERINE SUCTION | Engineering, Inc. | 1986-07-18 |
| K850312 | GYNASPYR VACUUM CURETTAGE UNIT | Roseburg SA | 1985-02-28 |
| K841631 | MODEL 3014 SUCTION UNIT | Forma Scientific, Inc. | 1984-07-03 |
| K840381 | TAPERED CERVICAL DILATOR | Intl. Medical Technologies, Inc. | 1984-04-30 |
| K840382 | VACUUM ASPIRATION CATHETER | Intl. Medical Technologies, Inc. | 1984-04-30 |
Legacy Summary#
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FDA Review#
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