The following data is part of a premarket notification filed by Mr Associates, Inc. with the FDA for M.r. Assoc. Snares; Crescent Snare Wire.
Device ID | K800965 |
510k Number | K800965 |
Device Name: | M.R. ASSOC. SNARES; CRESCENT SNARE WIRE |
Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
Applicant | MR ASSOCIATES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNS |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-23 |
Decision Date | 1980-05-08 |