510(k) K950639
- Device
- KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS
- Applicant
- KARL STORZ ENDOSCOPY-AMERICA, INC.
- 510(k) number
- K950639
- Product code
- MOK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-06-19
- Date received
- 1995-02-13
- Regulation
- 884.1630
- Classification name
- Vaginoscope And Accessories
- 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
- RENATE A MACLAREN
- Address
- 600 Corporate Pt.e Culver City CA US 90230 90230
FDA Registration Numbers#
- 3010707607
- 3010202439
- 9610617
- 3009051888
- 2020550
- 2027111
- 3014342096
Source Documents#
Other 510(k) Records For Product Code MOK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220969 | GelPOINT V-Path Vaginal Access System | Applied Medical Resources Corporation | 2022-09-16 |
Legacy Summary#
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FDA Review#
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