The following data is part of a premarket notification filed by Angiomed U.s., Inc. with the FDA for Angiomed Vac-u-cut Biopsy Needle.
Device ID | K862805 |
510k Number | K862805 |
Device Name: | ANGIOMED VAC-U-CUT BIOPSY NEEDLE |
Classification | Needle, Aspiration And Injection, Reusable |
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 | GDM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-22 |
Decision Date | 1986-09-29 |