510(k) K002653
- Device
- MMN-1 COARSE MANIPULATOR
- Applicant
- NARISHIGE CO., LTD.
- 510(k) number
- K002653
- Product code
- MQJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-09-22
- Date received
- 2000-08-25
- Regulation
- 884.6150
- Classification name
- Micromanipulators And Microinjectors, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MITSUKO YONEYAMA
- Address
- 27-9 Minamikarasuyama 4-Chome Setagaya-Ku, Tokyo JP 157-0062 157-0062
FDA Registration Numbers#
- 3016505000
- 3012637967
- 1820334
- 3005987240
- 3033740404
- 1825146
- 3012789229
- 1221433
- 3004871219
- 1000393132
- 3023235140
Source Documents#
Other 510(k) Records For Product Code MQJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142207 | TransferMan 4m Micromanipulator | Eppendorf AG | 2015-01-23 |
| K120877 | MICROMANIPULATOR SET | Narishige Co., Ltd. | 2012-06-20 |
| K113712 | IM-11 PNEUMATIC MICROINJECTOR | Narishige Co., Ltd. | 2012-03-15 |
| K011420 | MM-87 MOTOR-DRIVE MANIPULATOR | Narishige Co., Ltd. | 2001-06-12 |
| K010298 | MN-4 COARSE MANIPULATOR | Narishige Co., Ltd. | 2001-03-16 |
| K003142 | MICROMANIPULATOR | Research Instruments , Ltd. | 2000-11-22 |
| K003300 | MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR | Narishige Co., Ltd. | 2000-11-22 |
| K003302 | IM-5A INJECTOR | Narishige Co., Ltd. | 2000-11-22 |
| K003303 | IM-5B MICROINJECTOR | Narishige Co., Ltd. | 2000-11-22 |
| K003304 | IM-6 MICROINJECTOR | Narishige Co., Ltd. | 2000-11-22 |
| K003298 | MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR | Narishige Co., Ltd. | 2000-11-21 |
| K002850 | MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR | Narishige Co., Ltd. | 2000-10-05 |
| K002658 | MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR | Narishige Co., Ltd. | 2000-09-22 |
| K002659 | MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR | Narishige Co., Ltd. | 2000-09-22 |
| K002291 | MOTOR-DRIVE MANIPULATOR MM-89 | Narishige Co., Ltd. | 2000-09-13 |
Legacy Summary#
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FDA Review#
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