The following data is part of a premarket notification filed by Laser, Inc. with the FDA for Reusable Trocar With Safety Sleeve.
Device ID | K950021 |
510k Number | K950021 |
Device Name: | REUSABLE TROCAR WITH SAFETY SLEEVE |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | LASER, INC. 1803 BAKER DR. Tomball, TX 77375 -0434 |
Contact | William J Przybyla |
Correspondent | William J Przybyla LASER, INC. 1803 BAKER DR. Tomball, TX 77375 -0434 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-04 |
Decision Date | 1995-03-31 |