The following data is part of a premarket notification filed by Angiolaz, Inc. with the FDA for 50 W Metal Halide Illuminator, Ves 0501..
Device ID | K992447 |
510k Number | K992447 |
Device Name: | 50 W METAL HALIDE ILLUMINATOR, VES 0501. |
Classification | Light Source, Fiberoptic, Routine |
Applicant | ANGIOLAZ, INC. INDUSTRIAL PARK Bellows Falls, VT 05101 -0556 |
Contact | John Plumadore |
Correspondent | John Plumadore ANGIOLAZ, INC. INDUSTRIAL PARK Bellows Falls, VT 05101 -0556 |
Product Code | FCW |
Subsequent Product Code | FCR |
Subsequent Product Code | FFS |
Subsequent Product Code | GCT |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-22 |
Decision Date | 1999-10-20 |