The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Orc Endoscopic Instrument Holder.
Device ID | K930399 |
510k Number | K930399 |
Device Name: | ORC ENDOSCOPIC INSTRUMENT HOLDER |
Classification | Instrument, Manual, Surgical, General Use |
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 | MDM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-26 |
Decision Date | 1993-02-17 |