510(k) K945209
- Device
- PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTS
- Applicant
- KARL STORZ ENDOSCOPY-AMERICA, INC.
- 510(k) number
- K945209
- Product code
- GCF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-06
- Date received
- 1994-10-25
- Regulation
- 876.1500
- Classification name
- Proctoscope
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JUDITH K MURPHY
- Address
- 600 Corporate Pt.e Culver City CA US 90230 90230
FDA Registration Numbers#
- 3006546082
- 2020550
- 1315756
- 3010707607
- 9710524
- 8040233
- 9610617
- 3014342096
- 3006680097
- 3010202439
- 3004450489
Source Documents#
Other 510(k) Records For Product Code GCF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K790856 | PROCTOSCOPE #501 | C. Intl. | 1979-05-29 |
Legacy Summary#
summary
FDA Review#
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