The following data is part of a premarket notification filed by Medical Profiles, Inc. with the FDA for Excel Inflate-aid.
| Device ID | K883769 |
| 510k Number | K883769 |
| Device Name: | EXCEL INFLATE-AID |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDICAL PROFILES, INC. 13324 FARMINGTON RD. Lavonia, MI 48150 |
| Contact | Bone, Ii |
| Correspondent | Bone, Ii MEDICAL PROFILES, INC. 13324 FARMINGTON RD. Lavonia, MI 48150 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-06 |
| Decision Date | 1988-12-01 |