The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Injection Port Detector (ipd).
| Device ID | K963066 |
| 510k Number | K963066 |
| Device Name: | MENTOR INJECTION PORT DETECTOR (IPD) |
| Classification | Expander, Skin, Inflatable |
| Applicant | MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
| Contact | Ronald F Lagerquist |
| Correspondent | Ronald F Lagerquist MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-07 |
| Decision Date | 1996-09-27 |
| Summary: | summary |