The following data is part of a premarket notification filed by Oricare, Inc. with the FDA for Oricare L2700.
Device ID | K122875 |
510k Number | K122875 |
Device Name: | ORICARE L2700 |
Classification | Light, Surgical, Ceiling Mounted |
Applicant | ORICARE, INC. 1900 AM DRIVE Quakertown, PA 18951 |
Contact | David T Jamison |
Correspondent | David T Jamison ORICARE, INC. 1900 AM DRIVE Quakertown, PA 18951 |
Product Code | FSY |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-19 |
Decision Date | 2012-12-18 |
Summary: | summary |