FDA 510(k) Applications for Medical Device:
Headgear, Extraoral, Orthodontic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K955528 | CLP PRODUCTS |
502 TEAK DR. | LAKE PARK | FL | 33403 |
| K993224 | DONTECH PRODUCTS B.V. |
AVELINGENWEST 27C | GORINCHEM, ZH | ||
| K961754 | G & H WIRE CO. |
1791 INDUSTRIAL DR. | GREENWOOD | IN | 46142 |
| K041718 | GREAT LAKES ORTHODONTICS, LTD. |
200 COOPER AVE. | TONAWANDA | NY | 14151-5111 |
| K202855 | ITA.O Italian Orthodontic System S.r.l. |
Via Merighi, 30/3 - 30/4 | Villanova di Castenaso | 40055 | |
| K103019 | KJ MEDITECH CO., LTD |
951 STARBUCK ST. | FULLERTON | CA | 92833 |
| K111169 | KWANG MYUNG DAICOM INC |
951 STARBUCK ST. | FULLERTON | CA | 92833 |
| K982088 | ORTHO KINETICS CORP. |
1611A SOUTH MELROSE DRIVE, | VISTA | CA | 92083 |
| K980436 | ORTHO KINETICS CORP. |
1611A SOUTH MELROSE DR. | VISTA | CA | 92083-5407 |
| K980195 | ORTHO KINETICS CORP. |
1611A SOUTH MELROSE DR. | VISTA | CA | 92083-5407 |
| K980245 | ORTHO KINETICS CORP. |
1611A SOUTH MELROSE DR. | VISTA | CA | 92083-5407 |
| K980151 | ORTHO KINETICS CORP. |
1611A SOUTH MELROSE DRIVE, | VISTA | CA | 92083 |
| K051751 | ORTHO TECHNOLOGY |
17401 COMMERCE PARK BOULEVARD | TAMPA | FL | 33647 |
| K000358 | ORTHO TECHNOLOGY |
8909 REGENTS PARB DR., #410 | TAMPA | FL | 33647 |
| K032392 | ORTOSIM, S.A. DE C.V. |
13 RED FOX LANE | LITTLETON | CO | 80127 |
| K052553 | RUSSELL SAMUELS ORTHODONTIC DESIGN |
7 CRICKET LANE | LEICESTERSHIRE, ENGLAND | LE11 3PD | |
| K162543 | SAWBROS INDUSTRIES PVT.LTD. |
A-68 SECTOR 2 | NOIDA | 201301 |
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