The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Medi-vac Flexi-clear Suction Handle.
| Device ID | K964127 |
| 510k Number | K964127 |
| Device Name: | MEDI-VAC FLEXI-CLEAR SUCTION HANDLE |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Contact | Ingrid M Hoos |
| Correspondent | Ingrid M Hoos ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-15 |
| Decision Date | 1996-12-31 |
| Summary: | summary |