The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Insufflator Tubing/filter Kit.
Device ID | K922244 |
510k Number | K922244 |
Device Name: | INSUFFLATOR TUBING/FILTER KIT |
Classification | Insufflator, Laparoscopic |
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 | HIF |
CFR Regulation Number | 884.1730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-13 |
Decision Date | 1993-09-24 |