The following data is part of a premarket notification filed by Walla Medical Systems, Inc. with the FDA for Wall Iv Extension Tube.
| Device ID | K940689 |
| 510k Number | K940689 |
| Device Name: | WALL IV EXTENSION TUBE |
| Classification | Set, Administration, Intravascular |
| Applicant | WALLA MEDICAL SYSTEMS, INC. 5139 JIMMY CARTER BOULEVARD, SUITE 103 Norcross, GA 30093 |
| Contact | William H Wall |
| Correspondent | William H Wall WALLA MEDICAL SYSTEMS, INC. 5139 JIMMY CARTER BOULEVARD, SUITE 103 Norcross, GA 30093 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-16 |
| Decision Date | 1994-03-22 |