The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Argon Cut Biopsy Needles, Various Sizes.
| Device ID | K853312 |
| 510k Number | K853312 |
| Device Name: | ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES |
| Classification | Needle, Biopsy, Cardiovascular |
| Applicant | ARGON MEDICAL CORP. 1445 FLAT CREEK RD. P.O. BOX 1970 Athens, TX 75751 |
| Contact | Russell Jones |
| Correspondent | Russell Jones ARGON MEDICAL CORP. 1445 FLAT CREEK RD. P.O. BOX 1970 Athens, TX 75751 |
| Product Code | DWO |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-07 |
| Decision Date | 1985-09-12 |