The following data is part of a premarket notification filed by Pillar Surgical, Inc. with the FDA for Pillar Malar Implant.
Device ID | K992240 |
510k Number | K992240 |
Device Name: | PILLAR MALAR IMPLANT |
Classification | Implant, Malar |
Applicant | PILLAR SURGICAL, INC. P.O. BOX 8141 La Jolla, CA 92038 |
Contact | Rob Fritzenkotter |
Correspondent | Rob Fritzenkotter PILLAR SURGICAL, INC. P.O. BOX 8141 La Jolla, CA 92038 |
Product Code | LZK |
CFR Regulation Number | 878.3550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-02 |
Decision Date | 1999-11-22 |
Summary: | summary |