The following data is part of a premarket notification filed by Laserscope with the FDA for Add Power Family , Micro Addstat.
Device ID | K945614 |
510k Number | K945614 |
Device Name: | ADD POWER FAMILY , MICRO ADDSTAT |
Classification | Powered Laser Surgical Instrument |
Applicant | LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
Contact | Donna Page |
Correspondent | Donna Page LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-15 |
Decision Date | 1995-05-15 |