The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Pathway Introducer/dilator.
Device ID | K981527 |
510k Number | K981527 |
Device Name: | MENTOR PATHWAY INTRODUCER/DILATOR |
Classification | System, Suction, Lipoplasty |
Applicant | MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
Contact | Donna A Crawford |
Correspondent | Donna A Crawford MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-04-28 |
Decision Date | 1998-07-09 |
Summary: | summary |