The following data is part of a premarket notification filed by Wfr/aquaplast Corp. with the FDA for Accufix Tilting Radiotranslucent Headholder.
| Device ID | K021124 |
| 510k Number | K021124 |
| Device Name: | ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER |
| Classification | Accelerator, Linear, Medical |
| Applicant | WFR/AQUAPLAST CORP. 30 LAWLINS PARK Wyckoff, NJ 07481 |
| Contact | J Damon Kirk |
| Correspondent | J Damon Kirk WFR/AQUAPLAST CORP. 30 LAWLINS PARK Wyckoff, NJ 07481 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-08 |
| Decision Date | 2002-07-02 |