The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Obturator.
| Device ID | K894157 |
| 510k Number | K894157 |
| Device Name: | OBTURATOR |
| Classification | Introducer, Catheter |
| Applicant | ARGON MEDICAL CORP. 1445 FLAT CREEK RD. P.O. BOX 1970 Athens, TX 75751 |
| Contact | Clayton Koon |
| Correspondent | Clayton Koon ARGON MEDICAL CORP. 1445 FLAT CREEK RD. P.O. BOX 1970 Athens, TX 75751 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-14 |
| Decision Date | 1989-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333210507 | K894157 | 000 |
| 20886333210491 | K894157 | 000 |