FDA 510(k) Applications Submitted by MICHELE VOVOLKA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110198 |
01/24/2011 |
BLUE SKY BIO TCP |
BLUE SKY BIO, LLC |
| K002691 |
08/29/2000 |
COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE |
COM-MED INTERNATIONAL, INC. |
| K112875 |
09/30/2011 |
BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS |
BLUE SKY BIO, LLC |
| K153064 |
10/22/2015 |
Blue Sky Bio Zygomatic Implant System |
BLUE SKY BIO, LLC |
| K063874 |
12/29/2006 |
DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM |
BLUE SKY BIO, LLC |
| K073713 |
12/31/2007 |
BLUE SKY BIO DENTAL IMPLANT SYSTEM |
BLUE SKY BIO, LLC |
| K101189 |
04/28/2010 |
REAVILLMED PRESSURE MONITORING SYSTEM AND PICC |
REAVILLMED |
| K011879 |
06/15/2001 |
3A DENTAL IMPLANT SYSTEM |
OSSECO BIOSOURCE, LTD |
| K022159 |
07/02/2002 |
PISTON SYRINGE & HYPODERMIC NEEDLE |
INTERNATIONAL MEDSURG CONNECTION |
| K071858 |
07/05/2007 |
DENTAL MATRIX BAND |
FLY CAST TECHNOLOGIES, INC. |
| K032229 |
07/21/2003 |
QUANTUM WARP 10 LIGHT DELIVERY SYSTEM |
QUANTUM DEVICES, INC. |
| K072550 |
09/10/2007 |
SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301 |
MEDEVICE, INC. |
| K993358 |
10/06/1999 |
SIGHTSURE OPERATION INDICATOR, MODEL SS301 |
MEDEVICES, INC. |
| K023808 |
11/14/2002 |
IRRIGATION SETS |
INTERNATIONAL MEDSURG CONNECTION |
| K013958 |
11/30/2001 |
INDUS TEXTILES TOWEL-STERILE AND NON-STERILE |
INDUS TEXTILES, INC. |
| K014239 |
12/26/2001 |
MEDSURG EQUIPMENT COVERS |
INTERNATIONAL MEDSURG CONNECTION |
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