The following data is part of a premarket notification filed by Meridian Co., Ltd. with the FDA for Lapex Bcs.
Device ID | K081962 |
510k Number | K081962 |
Device Name: | LAPEX BCS |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | MERIDIAN CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm MERIDIAN CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-07-09 |
Decision Date | 2008-12-29 |
Summary: | summary |