The following data is part of a premarket notification filed by Cp Medical with the FDA for Cannula Clamp.
Device ID | K853538 |
510k Number | K853538 |
Device Name: | CANNULA CLAMP |
Classification | Clamp |
Applicant | CP MEDICAL 1775 WHITTIER AVE. Costa Mesa, CA 92627 |
Contact | Carl Grodach |
Correspondent | Carl Grodach CP MEDICAL 1775 WHITTIER AVE. Costa Mesa, CA 92627 |
Product Code | HXD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-23 |
Decision Date | 1985-09-12 |