The following data is part of a premarket notification filed by Laser, Inc. with the FDA for Grasping Forceps, Punches, Scissors.
Device ID | K940454 |
510k Number | K940454 |
Device Name: | GRASPING FORCEPS, PUNCHES, SCISSORS |
Classification | Arthroscope |
Applicant | LASER, INC. P.O. BOX 358 Tomball, TX 77375 |
Contact | Wm. J Przybyla |
Correspondent | Wm. J Przybyla LASER, INC. P.O. BOX 358 Tomball, TX 77375 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-01 |
Decision Date | 1994-03-25 |