The following data is part of a premarket notification filed by Mitsubishi Cable America, Inc. with the FDA for Endoscope Introducer Kit.
| Device ID | K955717 |
| 510k Number | K955717 |
| Device Name: | ENDOSCOPE INTRODUCER KIT |
| Classification | Laparoscopy Kit |
| Applicant | MITSUBISHI CABLE AMERICA, INC. 10551 WULFF DR. Orange, CA 92667 |
| Contact | Ronald J Ehmsen |
| Correspondent | Ronald J Ehmsen MITSUBISHI CABLE AMERICA, INC. 10551 WULFF DR. Orange, CA 92667 |
| Product Code | FDE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-18 |
| Decision Date | 1996-04-18 |
| Summary: | summary |