FDA 510(k) Applications for Medical Device:
Bronchoscope Accessory
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K090660 | ACCLARENT, INC. |
1525-B O'BRIEN DR. | MENLO PARK | CA | 94025 |
| K110218 | ACCLARENT, INC. |
1525-B O'BRIEN DR. | MENLO PARK | CA | 94025 |
| K241679 | Alton (Shanghai) Medical Instruments Co. Ltd |
No.24 Building Jinshao Rd.1688.Baoshan District | Shanghai | 200949 | |
| K082174 | ASTHMATX, INC. |
888 ROSS DRIVE | SUNNYVALE | CA | 94089 |
| K023337 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PLACE | NATICK | MA | 01760-1537 |
| K020765 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PLACE | NATICK | MA | 01760-1537 |
| K170759 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K150951 | Bryan Medical , Inc. |
3906 Oak St. | Cincinnati | OH | 45227 |
| K211894 | DISA Medinotec |
Stand 171, Northlands Business Park, Bush Telegraph Street | Johannesburg | 2169 | |
| K222187 | Dongguan TT Medical, Inc. |
BLD#1, 1 Taoyuan Road, Songshan Lake | Dongguan | 523808 | |
| K230280 | GA Health Company Limited |
Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin | Hong Kong | ||
| K153484 | INTUIT MEDICAL PRODUCTS, LLC |
6018 EAGLES REST TRAIL | SUGAR HILL | GA | 30518 |
| K231818 | M/s Meril Life Sciences Pvt. Ltd. |
Survey No. 135/139, Bilakhia House, | Vapi | 396191 | |
| K151522 | MEDIVATORS, INC. |
3150 POLLOK DR. | CONROE | TX | 77303 |
| K161392 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PARKWAY | SOUTH JORDAN | UT | 84095 |
| K213434 | Merit Medical Systems, Inc. |
1600 West Merit Parkway | South Jordan | UT | 84095 |
| K213060 | Micro-Tech (Nanjing) Co., Ltd. |
No. 10 Gaoke Third Road, | Nanjing | 210032 | |
| K250263 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachiochi-Shi | 192-8507 | |
| K190239 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-Shi | 192-8507 | |
| K171232 | Olympus Surgical Technologies America |
136 Turnpike Road | Southborough | MA | 01772-2104 |
| K181193 | Olympus Surgical Technologies America |
136 Turnpike Road | Southborough | MA | 01772-2104 |
| K163469 | Olympus Surgical Technologies America |
136 Turnpike Road | Southborough | MA | 01772-2104 |
| K193517 | Olympus Surgical Technologies America |
136 Turnpike Road | Southborough | MA | 01772-2104 |
| K230778 | Praxis Medical, LLC |
500 N Willow Ave. Ste 101 | Tampa | FL | 33606 |
| K221206 | Serpex Medical, Inc. |
3350 Scott Blvd, Suite 37B | Santa Clara | CA | 95054 |
| K152922 | SPIRATION, INC. |
6675 185th Ave NE | REDMOND | WA | 98052 |
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