The following data is part of a premarket notification filed by Dickson & Dickson Healthcare (us), Inc with the FDA for Claveguard Freedom Surgical Light.
Device ID | K142076 |
510k Number | K142076 |
Device Name: | CLAVEGUARD FREEDOM SURGICAL LIGHT |
Classification | Light, Surgical, Ceiling Mounted |
Applicant | DICKSON & DICKSON HEALTHCARE (US), INC 503 CANAL BLVD Richmond, CA 94804 |
Contact | Ragunath Muniandy |
Correspondent | Ragunath Muniandy DICKSON & DICKSON HEALTHCARE (US), INC 503 CANAL BLVD Richmond, CA 94804 |
Product Code | FSY |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-31 |
Decision Date | 2014-09-30 |
Summary: | summary |