510(k) K855151
- Device
- FRITCH OPHTHALMIC ENDOSCOPE
- Applicant
- REGTEC
- 510(k) number
- K855151
- Product code
- GDB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-02-19
- Date received
- 1985-12-26
- Regulation
- 876.1500
- Classification name
- Endoscope, Fiber Optic
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOANN R SCHULZ
- Address
- P.O. Box 76298 St. Petersburg FL US 33734 33734
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GDB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K032283 | DESIGNS FOR VISION FIBEROPTIC LIGHT | Designs For Vision, Inc. | 2003-08-20 |
| 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 |
| 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#
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FDA Review#
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