The following data is part of a premarket notification filed by Aranz Medical Limited with the FDA for Silhouette, Model 1000.01.
| Device ID | K070426 |
| 510k Number | K070426 |
| Device Name: | SILHOUETTE, MODEL 1000.01 |
| Classification | Tape, Camera, Surgical |
| Applicant | ARANZ MEDICAL LIMITED GROUND FLOOR ST ELMO COURTS 47 HEREFORD ST. PO BOX 3894 Christchurch, Canterbury, NZ 8013 |
| Contact | Shane Goodwin |
| Correspondent | Shane Goodwin ARANZ MEDICAL LIMITED GROUND FLOOR ST ELMO COURTS 47 HEREFORD ST. PO BOX 3894 Christchurch, Canterbury, NZ 8013 |
| Product Code | FXN |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-13 |
| Decision Date | 2007-06-29 |
| Summary: | summary |