510(k) K941660
- Device
- GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT
- Applicant
- GM ENGINEERING, INC.
- 510(k) number
- K941660
- Product code
- KYH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-05-24
- Date received
- 1994-04-05
- Regulation
- 876.1500
- Classification name
- Endoscope, Ophthalmic
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID C STEFFIN
- Address
- 2549 Sierra Way, Suite B La Verne CA US 91750 91750
FDA Registration Numbers#
- 2247224
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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