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 |