The following data is part of a premarket notification filed by Giotto Usa, Llc with the FDA for Biopsy Digit S Biopsy Sl.
| Device ID | K113607 |
| 510k Number | K113607 |
| Device Name: | BIOPSY DIGIT S BIOPSY SL |
| Classification | System, X-ray, Mammographic |
| Applicant | GIOTTO USA, LLC 81 SEACOUNTRY LANE Rancho Santa Margarita, CA 92688 |
| Contact | Nicolaas Besseling |
| Correspondent | Nicolaas Besseling GIOTTO USA, LLC 81 SEACOUNTRY LANE Rancho Santa Margarita, CA 92688 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-06 |
| Decision Date | 2012-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056977360090 | K113607 | 000 |