The following data is part of a premarket notification filed by Bionix Development Corp. with the FDA for 3-way Head Immobilizer; 3way Deluxe Reusable Frame Head Immobilizer.
| Device ID | K933613 |
| 510k Number | K933613 |
| Device Name: | 3-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZER |
| Classification | Accelerator, Linear, Medical |
| Applicant | BIONIX DEVELOPMENT CORP. 5154 ENTERPRISE BLVD. Toledo, OH 43612 |
| Contact | Richard A Wasserman |
| Correspondent | Richard A Wasserman BIONIX DEVELOPMENT CORP. 5154 ENTERPRISE BLVD. Toledo, OH 43612 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-19 |
| Decision Date | 1993-10-07 |