The following data is part of a premarket notification filed by Pierrel Pharma S.r.l. with the FDA for G.o.c.c.l.e.s..
| Device ID | K151630 |
| 510k Number | K151630 |
| Device Name: | G.o.c.c.l.e.s. |
| Classification | Diagnostic Light, Soft Tissue Detector |
| Applicant | PIERREL PHARMA S.R.L. STRADA STATALE APPIA 46/48 Capua, IT 81043 |
| Contact | Fabio Velotti |
| Correspondent | Maurizio Pantaleoni ISEMED SRL VIA A. BONETTI 3/A Imola, IT 40026 |
| Product Code | NXV |
| CFR Regulation Number | 872.6350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-17 |
| Decision Date | 2015-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08051040582010 | K151630 | 000 |
| 08051040582003 | K151630 | 000 |