510(k) K935247
- Device
- JEDMED COMPACT ENDOSCOPIC BEAMSPLITTER
- Applicant
- JEDMED INSTRUMENT CO.
- 510(k) number
- K935247
- Product code
- FEA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-02-18
- Date received
- 1993-11-01
- Regulation
- 876.1500
- Classification name
- Attachment, Teaching, For Endoscope
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CRAIG R PARKS
- Address
- 6096 Lemay Ferry Rd. St.Louis MO US 63129 63129
FDA Registration Numbers#
- 3027518263
- 3010202439
- 9610877
- 3010041511
- 2020550
- 3003782610
- 3008797804
- 3011137372
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FEA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K791635 | AO TEACHING ATTACHMENT, MODEL TA-1 | American Optical Corp. | 1979-09-24 |
Legacy Summary#
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FDA Review#
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