ENDOMARK STERILE INDIA INK
FDA 510(k) clearance K042901 · decided 2005-03-16
Clearance details
- K-number
- K042901
- Device name
- ENDOMARK STERILE INDIA INK
- Applicant
- Pmt Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-10-20
- Decision date
- 2005-03-16
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- NBG
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Chanhassen, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SPOT ENDOSCOPIC MARKER (K993951) | Chek-Med Systems | 2000-02-18 |
Recalls involving this device
No recalls on record reference this clearance.