The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Laparoscopic Suction/irrigation Probe.
Device ID | K920643 |
510k Number | K920643 |
Device Name: | LAPAROSCOPIC SUCTION/IRRIGATION PROBE |
Classification | Catheter, Cholangiography |
Applicant | O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke, TX 76262 |
Contact | John Mayall |
Correspondent | John Mayall O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke, TX 76262 |
Product Code | GBZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-12 |
Decision Date | 1992-05-06 |