The following data is part of a premarket notification filed by Laser, Inc. with the FDA for Disposable Insufflation Tubing.
Device ID | K932045 |
510k Number | K932045 |
Device Name: | DISPOSABLE INSUFFLATION TUBING |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | LASER, INC. P.O. BOX 358 Tomball, TX 77375 |
Contact | Keith Przybyla |
Correspondent | Keith Przybyla LASER, INC. P.O. BOX 358 Tomball, TX 77375 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-27 |
Decision Date | 1993-09-23 |