The following data is part of a premarket notification filed by Kbl Gmbh with the FDA for Kbl 7000 Alpha Hybridsun, Kbl 7900 Alpha Hybridsun, Kbl 8000 Alpha Hybridsun.
| Device ID | K191881 |
| 510k Number | K191881 |
| Device Name: | KBL 7000 Alpha HybridSun, KBL 7900 Alpha HybridSun, KBL 8000 Alpha HybridSun |
| Classification | Booth, Sun Tan |
| Applicant | KBL GmbH Ringstrasse 24-26 Dernbach, DE 56307 |
| Contact | Ralf De Andreis |
| Correspondent | Ralf De Andreis KBL GmbH Ringstrasse 24-26 Dernbach, DE 56307 |
| Product Code | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-15 |
| Decision Date | 2019-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260489020166 | K191881 | 000 |
| 04260489020142 | K191881 | 000 |
| 04260489020135 | K191881 | 000 |
| 04260489020128 | K191881 | 000 |
| 04260489020210 | K191881 | 000 |
| 04260489020395 | K191881 | 000 |
| 04260489020371 | K191881 | 000 |