The following data is part of a premarket notification filed by Pelton & Crane Co. with the FDA for Sirolux Fantastic.
Device ID | K935390 |
510k Number | K935390 |
Device Name: | SIROLUX FANTASTIC |
Classification | Light, Operating, Dental |
Applicant | PELTON & CRANE CO. P.O. BOX 7800 Charlotte, NC 28241 -7800 |
Contact | Kristi Kunkel |
Correspondent | Kristi Kunkel PELTON & CRANE CO. P.O. BOX 7800 Charlotte, NC 28241 -7800 |
Product Code | EAZ |
CFR Regulation Number | 872.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-08 |
Decision Date | 1993-12-10 |