Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K951398
Device Name MIST REDUCER SLEEVES
Applicant
MINIMALLY INVASIVE SURGICAL TECHNOLOGIES, INC.
55 NORTHERN BLVD.
SUITE 410
GREAT NECK,  NY  11021
Applicant Contact CAROLANN KOTULA
Correspondent
MINIMALLY INVASIVE SURGICAL TECHNOLOGIES, INC.
55 NORTHERN BLVD.
SUITE 410
GREAT NECK,  NY  11021
Correspondent Contact CAROLANN KOTULA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/28/1995
Decision Date 05/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-