The following data is part of a premarket notification filed by Wfr/aquaplast Corp. with the FDA for Accufix Radiolucent Pelvis And Belly Boards, Accufix Cantilever Head Board With Shoulder Depression, Accufix Radiolucent.
| Device ID | K032156 |
| 510k Number | K032156 |
| Device Name: | ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT |
| 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 | 2003-07-14 |
| Decision Date | 2003-09-02 |