FDA 510(k) Applications Submitted by KEVIN M RANDALL
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K010013 |
01/02/2001 |
LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 |
VALLEYLAB, INC. |
| K120127 |
01/17/2012 |
SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM |
SWAN VALLEY MEDICAL, INCORPORATED |
| K070308 |
02/01/2007 |
FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR |
X-CEL CONTACTS |
| K080686 |
03/11/2008 |
WESTCON HORIZON 49% (HIOXIFILCON B) |
WESTCON CONTACT LENS CO. |
| K111345 |
05/13/2011 |
SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS |
THE SEE CLEAR COMPANY, INC |
| K072554 |
09/10/2007 |
ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES |
SABLE INDUSTRIES, INC. |
| K133079 |
09/30/2013 |
IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC) |
ALDEN OPTICAL LABS., INC. |
| K083101 |
10/20/2008 |
PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES |
SABLE INDUSTRIES, INC. |
| K970312 |
01/27/1997 |
CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A) |
FLEXLENS, INC. |
| K001908 |
06/22/2000 |
KONTUR 55 SOFT LENS |
KONTUR KONTACT LENS CO., INC. |
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