The following data is part of a premarket notification filed by T. Koros Surgical Instruments Corp. with the FDA for Endoscopic Or Thorascopic Forceps.
Device ID | K931259 |
510k Number | K931259 |
Device Name: | ENDOSCOPIC OR THORASCOPIC FORCEPS |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | T. KOROS SURGICAL INSTRUMENTS CORP. 610 FLINN AVE. Moorpark, CA 93021 |
Contact | Gabriel Koros |
Correspondent | Gabriel Koros T. KOROS SURGICAL INSTRUMENTS CORP. 610 FLINN AVE. Moorpark, CA 93021 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-12 |
Decision Date | 1993-06-08 |