FDA 510(k) Applications for Medical Device:
Dilator, Vaginal
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K003380 | BIOTEQUE AMERICA, INC. |
340 EAST MAPLE AVE., #204-C | LANGHORNE | PA | 19047 |
| K071754 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K233689 | Lujena, Inc. |
11447 Rolling Hills Dr. | El Cajon | CA | 92020 |
| K222492 | Lujena, Inc. |
772 Jamacha Rd., #800 | El Cajon | CA | 92019 |
| K211959 | Materna Medical |
2495 Hospital Drive Suite 300 | Mountain View | CA | 94040 |
| K220035 | Materna Medical |
2495 Hospital Drive, Suite 300 | Mountain View | CA | 94040 |
| K130273 | Panpac Medical Corporation |
6F-1, 2 NO. 202, SEC 3 | SHI-CHIH DISTRICT, NEW TAIPEI CITY | 22103 | |
| K241748 | Plus EV Holdings dba Intimate Rose |
1419 Murray St | North Kansas City | MO | 64116 |
| K231430 | Plus EV Holdings dba Intimate Rose |
1419 Murray Street | North Kansas City | MO | 64116 |
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