FDA 510(k) Applications Submitted by MICHAEL LEE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| DEN050001 |
01/24/2005 |
DECAPINOL ORAL RINSE |
SINCLAIR PHARMACEUTICALS LIMITED |
| K040950 |
04/12/2004 |
ALOCLAIR ORAL GEL |
SINCLAIR PHARMACEUTICALS, LTD. |
| K042722 |
10/01/2004 |
ALOCLAIR ORAL SPRAY |
SINCLAIR PHARMACEUTICALS, LTD. |
| K053166 |
11/14/2005 |
SINCLAIR ORAL RINSE |
SINCLAIR PHARMACEUTICALS LIMITED |
| K024367 |
12/31/2002 |
SINCLAIR WOUND AND SKIN EMULSION |
SINCLAIR PHARMACEUTICALS, LTD. |
| K110027 |
01/05/2011 |
SURGICAL FACE MASK; SURGICAL FACE MASK |
ANGELINE GROUP LTD. |
| K110425 |
02/14/2011 |
HC-BIOS DENTAL IMPLANT |
HUNG CHUN BIO-S CO., LTD. |
| K100977 |
04/08/2010 |
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE |
JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD |
| K100978 |
04/08/2010 |
POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE |
JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD |
| K100979 |
04/08/2010 |
NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE |
JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD |
| K100975 |
04/09/2010 |
NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE |
JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD |
| K140913 |
04/10/2014 |
NUROS BONE GRAFT SUBSTITUTE |
ORIENTAL RESOURCES DEVELOPMENT LIMITED |
| K141064 |
04/24/2014 |
VESOFLOW PLUS DVT COMPRESSION DEVICE |
CAREMED SUPPLY, INC. |
| K111441 |
05/24/2011 |
UNIMAX VERESS NEEDLE |
UNIMAX MEDICAL SYSTEMS, INC. |
| K091714 |
06/10/2009 |
ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 |
SKYFINE INC. LIMITED |
| K111622 |
06/10/2011 |
UNIMAX ANTI-FOG SOLUTION |
UNIMAX MEDICAL SYSTEMS, INC. |
| K141917 |
07/15/2014 |
UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR |
UNICON OPTICAL CO., LTD. |
| K112358 |
08/16/2011 |
UNIMAX TROCAR SYSTEM |
UNIMAX MEDICAL SYSTEMS, INC. |
| K122873 |
09/19/2012 |
VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS |
CAREMED SUPPLY, INC. |
| K112853 |
09/29/2011 |
VOLTERA POWERED SUCTION PUMP |
SUZRIC ENTERPRISE CO., LTD. |
| K133105 |
09/30/2013 |
BREEZE NEBULIZER (NBR-10X) |
DIGIO2 INTERNATIONAL CO., LTD |
| K123061 |
10/01/2012 |
ACE MONOPOLAR ATTACHMENT |
BIOECONEER INC. |
| K103061 |
10/18/2010 |
BIOMATE STERILE ACUPUNCTURE NEEDLE |
BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. |
| K103508 |
11/29/2010 |
UNMIAX LAPAROSCOPIC INSTRUMENT |
UNIMAX MEDICAL SYSTEMS, INC. |
| K103509 |
11/29/2010 |
UNIMAX SUCTION IRRIGATION SET |
UNIMAX MEDICAL SYSTEMS, INC. |
| K103510 |
11/29/2010 |
UNIMAX SPECIMEN RETRIEVAL SYSTEM |
UNIMAX MEDICAL SYSTEMS, INC. |
| K122075 |
07/16/2012 |
DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER |
INTERSURGICAL, INC. |
| K141945 |
07/17/2014 |
ECHOSTAR COMFORT 1.5T MRI |
ALLTECH MEDICAL SYSTEMS AMERICA, INC. |
| K163192 |
11/15/2016 |
Comfort EC710 |
ALLTECH MEDICAL SYSTEMS AMERICA, INC. |
| K113511 |
11/28/2011 |
ECHOSTAR SPICA 1.5T MR SYSTEM |
ALLTECH MEDICAL SYSTEMS AMERICA, INC. |
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