The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Endomark Sterile India Ink.
| Device ID | K042901 |
| 510k Number | K042901 |
| Device Name: | ENDOMARK STERILE INDIA INK |
| Classification | Marker, Colon |
| Applicant | PMT CORP. 1500 PARK RD Chanhassen, MN 55317 |
| Contact | James R Veale |
| Correspondent | James R Veale MEDICAL DEVICE CONSULTANTS, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | NBG |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-20 |
| Decision Date | 2005-03-16 |
| Summary: | summary |