The following data is part of a premarket notification filed by Angiomed U.s., Inc. with the FDA for Angio Med Disposable Pressure Connectors.
Device ID | K855078 |
510k Number | K855078 |
Device Name: | ANGIO MED DISPOSABLE PRESSURE CONNECTORS |
Classification | Accessories, Catheter |
Applicant | ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim, CA 92807 |
Contact | Richard P Mohr |
Correspondent | Richard P Mohr ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim, CA 92807 |
Product Code | KGZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-19 |
Decision Date | 1986-02-19 |