The following data is part of a premarket notification filed by Geritrex Corp. with the FDA for Grx Foam Dressing.
| Device ID | K945224 |
| 510k Number | K945224 |
| Device Name: | GRX FOAM DRESSING |
| Classification | Bandage, Liquid |
| Applicant | GERITREX CORP. 2 EAST SANFORD BLVD. Mount Vernon, NY 10550 -4510 |
| Contact | Anthony J Madaio |
| Correspondent | Anthony J Madaio GERITREX CORP. 2 EAST SANFORD BLVD. Mount Vernon, NY 10550 -4510 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-26 |
| Decision Date | 1995-04-03 |