The following data is part of a premarket notification filed by Minimally Invasive Surgical Technologies, Inc. with the FDA for Mist Scissors For Laparoscopic/endoscopic Procedur.
Device ID | K931272 |
510k Number | K931272 |
Device Name: | MIST SCISSORS FOR LAPAROSCOPIC/ENDOSCOPIC PROCEDUR |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | MINIMALLY INVASIVE SURGICAL TECHNOLOGIES, INC. CAROLANN KATULA-COOK 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
Contact | C/o M.d.i. |
Correspondent | C/o M.d.i. MINIMALLY INVASIVE SURGICAL TECHNOLOGIES, INC. CAROLANN KATULA-COOK 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-08 |
Decision Date | 1993-05-17 |