The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for O.r. Concepts' Irrigating Kittner.
Device ID | K923818 |
510k Number | K923818 |
Device Name: | O.R. CONCEPTS' IRRIGATING KITTNER |
Classification | Carrier, Sponge, Endoscopic |
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 | FGS |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-30 |
Decision Date | 1993-04-07 |