510(k) K032283
- Device
- DESIGNS FOR VISION FIBEROPTIC LIGHT
- Applicant
- DESIGNS FOR VISION, INC.
- 510(k) number
- K032283
- Product code
- GDB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-08-20
- Date received
- 2003-07-24
- Regulation
- 876.1500
- Classification name
- Endoscope, Fiber Optic
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY MCNAMARA-CULLINANE
- Address
- 49 Plain St. North Attleboro MA US 02760 02760
Source Documents#
Other 510(k) Records For Product Code GDB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K961536 | FLEXSCOPE | Matrix Medica, Inc. | 1996-09-18 |
| K935818 | ENDOSCOPE | Cuda Products Co. | 1994-07-13 |
| K882061 | OLYMPUS GF-UM3/EU-M3 | Olympus Corp. | 1988-11-15 |
| K855151 | FRITCH OPHTHALMIC ENDOSCOPE | Regtec | 1986-02-19 |
| K843900 | FOCUSCOPE UNIVERSAL SYSTEM | Medical Diagnostics, Ca. | 1984-12-06 |
| K810007 | PENTAX UPPER G.I. FIBERSCOPE, #FG-34 | Pentax Precision Instrument Corp. | 1981-01-15 |
Legacy Summary#
summary
FDA Review#
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