The following data is part of a premarket notification filed by Restore Medical Inc. with the FDA for Pillar Palatal Implant System.
Device ID | K040417 |
510k Number | K040417 |
Device Name: | PILLAR PALATAL IMPLANT SYSTEM |
Classification | Device, Anti-snoring |
Applicant | RESTORE MEDICAL INC. 2800 PATTON RD. St Paul, MN 55113 |
Contact | Edward W Numainville |
Correspondent | Edward W Numainville RESTORE MEDICAL INC. 2800 PATTON RD. St Paul, MN 55113 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-02-18 |
Decision Date | 2004-07-28 |
Summary: | summary |