510(k) K042901
- Device
- ENDOMARK STERILE INDIA INK
- Applicant
- PMT CORP.
- 510(k) number
- K042901
- Product code
- NBG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-03-16
- Date received
- 2004-10-20
- Regulation
- 876.1500
- Classification name
- Marker, Colon
- 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
- JAMES R VEALE
- Address
- 1500 Park Rd. Chanhassen MN US 55317 55317
FDA Registration Numbers#
- 3005248192
- 1528319
- 3013734919
- 3013440400
- 3004837686
- 3014718111
- 3013337852
- 2182979
- 2132588
Source Documents#
Other 510(k) Records For Product Code NBG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993951 | SPOT ENDOSCOPIC MARKER | Chek-Med Systems | 2000-02-18 |
Legacy Summary#
summary
FDA Review#
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