The following data is part of a premarket notification filed by Geritrex Corp. with the FDA for Geritrex Sterile Saline Wet Dressing.
Device ID | K931510 |
510k Number | K931510 |
Device Name: | GERITREX STERILE SALINE WET DRESSING |
Classification | Gauze, External (with Drug/biologic/animal Source Material) |
Applicant | GERITREX CORP. 2 EAST SANFORD BLVD. Mount Vernon, NY 10550 -4510 |
Contact | Anthony Madaio |
Correspondent | Anthony Madaio GERITREX CORP. 2 EAST SANFORD BLVD. Mount Vernon, NY 10550 -4510 |
Product Code | GER |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-26 |
Decision Date | 1993-07-13 |