The following data is part of a premarket notification filed by Pentax Medical Company with the FDA for Ec-3870cilk, Confocal Video Colonoscope.
| Device ID | K042741 |
| 510k Number | K042741 |
| Device Name: | EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | PENTAX MEDICAL COMPANY 102 CHESTNUT RIDGE ROAD Montvale, NJ 07645 |
| Contact | Paul Silva |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-10-04 |
| Decision Date | 2004-10-19 |
| Summary: | summary |