The following data is part of a premarket notification filed by Trebay Medical Corp. with the FDA for Micro-ingressor Handipiece.
| Device ID | K954796 |
| 510k Number | K954796 |
| Device Name: | MICRO-INGRESSOR HANDIPIECE |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | TREBAY MEDICAL CORP. 4911 CREEKSIDE DR. Clearwater, FL 34620 |
| Contact | Dab H Treace |
| Correspondent | Dab H Treace TREBAY MEDICAL CORP. 4911 CREEKSIDE DR. Clearwater, FL 34620 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-18 |
| Decision Date | 1995-11-06 |