510(k) K812810
- Device
- PENTAX FLEXIBLE DRIODENOFIBERSCOPE
- Applicant
- PENTAX PRECISION INSTRUMENT CORP.
- 510(k) number
- K812810
- Product code
- FAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-11-17
- Date received
- 1981-10-06
- Regulation
- 876.1500
- Classification name
- Panendoscope (gastroduodenoscope)
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FAK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K760822 | MODEL TX-8 PANENDOSCOPE | American Cystocope Makers, Inc. | 1976-10-21 |
Legacy Summary#
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FDA Review#
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