The following data is part of a premarket notification filed by Gynex Corp. with the FDA for Gynex Extended Reach Needle.
| Device ID | K980238 |
| 510k Number | K980238 |
| Device Name: | GYNEX EXTENDED REACH NEEDLE |
| Classification | Set, Anesthesia, Paracervical |
| Applicant | GYNEX CORP. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf GYNEX CORP. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | HEE |
| CFR Regulation Number | 884.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-23 |
| Decision Date | 1998-08-21 |
| Summary: | summary |