The following data is part of a premarket notification filed by Laser, Inc. with the FDA for Titanium Probes.
Device ID | K852415 |
510k Number | K852415 |
Device Name: | TITANIUM PROBES |
Classification | Retractor |
Applicant | LASER, INC. P.O. BOX 358 Tomball, TX 77375 |
Contact | William Przyby |
Correspondent | William Przyby LASER, INC. P.O. BOX 358 Tomball, TX 77375 |
Product Code | GAD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-07 |
Decision Date | 1985-08-02 |