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 catheter, irrigation
510(k) Number K895755
Device Name MIKRO-LAVAGE-1
Applicant
MIKRO-TEK LABORATORIES
220 SOUTH LORI LN.
BLOOMINGTON,  IN  47401
Applicant Contact THOMAS P CLEMENT
Correspondent
MIKRO-TEK LABORATORIES
220 SOUTH LORI LN.
BLOOMINGTON,  IN  47401
Correspondent Contact THOMAS P CLEMENT
Regulation Number878.4200
Classification Product Code
GBX  
Date Received09/26/1989
Decision Date 12/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-