The following data is part of a premarket notification filed by Kamber Corporation with the FDA for Robin Hood Vest.
Device ID | K051300 |
510k Number | K051300 |
Device Name: | ROBIN HOOD VEST |
Classification | Holder, Infant Position |
Applicant | KAMBER CORPORATION 1301 K STREET, N.W. SUITE 1100 - EAST TOWER Washington, DC 20005 -3373 |
Contact | David J Bloch |
Correspondent | David J Bloch KAMBER CORPORATION 1301 K STREET, N.W. SUITE 1100 - EAST TOWER Washington, DC 20005 -3373 |
Product Code | FRP |
CFR Regulation Number | 880.5680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-18 |
Decision Date | 2005-12-08 |
Summary: | summary |