The following data is part of a premarket notification filed by A.r.c. Laser Ag with the FDA for A.r.c. Low Bubble Turbo Needle, Model We0106.5.
Device ID | K002986 |
510k Number | K002986 |
Device Name: | A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 |
Classification | Unit, Phacofragmentation |
Applicant | A.R.C. LASER AG 2417 SOUTH 3850 WEST Salt Lake City, UT 84120 |
Contact | Daniel Hoefer |
Correspondent | Daniel Hoefer A.R.C. LASER AG 2417 SOUTH 3850 WEST Salt Lake City, UT 84120 |
Product Code | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-09-25 |
Decision Date | 2000-11-29 |