The following data is part of a premarket notification filed by Anchor Products Co. with the FDA for Anchor Biopsy Needle.
Device ID | K873124 |
510k Number | K873124 |
Device Name: | ANCHOR BIOPSY NEEDLE |
Classification | Needle, Aspiration And Injection, Disposable |
Applicant | ANCHOR PRODUCTS CO. 52 OFFICIAL RD. Addison, IL 60101 |
Contact | Robert H Thrun |
Correspondent | Robert H Thrun ANCHOR PRODUCTS CO. 52 OFFICIAL RD. Addison, IL 60101 |
Product Code | GAA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-10 |
Decision Date | 1987-09-08 |