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 |