The following data is part of a premarket notification filed by Tnt Moborg Intl. Ltd. with the FDA for Immobile Sterile And Immobile A/c Sterile.
| Device ID | K941940 |
| 510k Number | K941940 |
| Device Name: | IMMOBILE STERILE AND IMMOBILE A/C STERILE |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | TNT MOBORG INTL. LTD. 693 SENECA ST. Buffalo, NY 14210 |
| Contact | Dennis R Tollini |
| Correspondent | Dennis R Tollini TNT MOBORG INTL. LTD. 693 SENECA ST. Buffalo, NY 14210 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-21 |
| Decision Date | 1994-07-14 |