FDA 510(k) Applications for Medical Device:
Duodenoscope And Accessories, Flexible/Rigid
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K233886 | Ambu A/S |
Baltorpbakken 13 | Ballerup | 2750 | |
| K201098 | Ambu Innovation GmbH |
Peterhofstr 3b | Kissing | 86438 | |
| K110833 | Boston Scientific Corporation |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K193202 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K203028 | Fujifilm Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K181745 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K182051 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K191747 | FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi | Ashigarakami-Gun | 258-8538 | |
| K152257 | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
10 HIGH POINT DRIVE | WAYNE | NJ | 07470 |
| K042076 | FUJINON, INC. |
P.O. BOX 2156 | HUNTINGTON | CT | 06484 |
| K962212 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K980465 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K143153 | OLYMPUS MEDICAL SYSTEMS CORP. |
2951 ISHIKAWA-CHO | HACHIOJI-SHI | 192-8507 | |
| K193182 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-Shi | 192-8507 | |
| K202661 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K220587 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K080403 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034-0610 |
| K024033 | OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K192280 | Pentax Medical |
3 Paragon Drive | Montvale | NJ | 07645 |
| K161222 | PENTAX MEDICAL |
3 PARAGON DRIVE | MONTVALE | NJ | 07645 |
| K163614 | PENTAX Medical |
3 Paragon Drive | Montvale | NJ | 07645 |
| K092710 | PENTAX MEDICAL COMPANY |
102 CHESTNUT RIDGE RD. | MONTVALE | NJ | 07645-1856 |
| K181522 | PENTAX of America, Inc. |
3 Paragon Drive | Montvale | NJ | 07645-1782 |
| K210710 | PENTAX of America, Inc. |
3 Paragon Drive | Montvale | NJ | 07645-1782 |
| K233942 | Pentax of America, Inc. |
3 Paragon Drive | Montvale | NJ | 07645 |
| K202365 | Pentax of America, Inc. |
3 Paragon Drive | Montvale | NJ | 07645-1782 |
| K192245 | PENTAX of America, Inc. |
3 Paragon Drive | Montvale | NJ | 07645-1782 |
| K963056 | PENTAX PRECISION INSTRUMENT CORP. |
3117 COMMERCE PKWY. | MIRAMAR | FL | 33025 |
| K961568 | PENTAX PRECISION INSTRUMENT CORP. |
3117 COMMERCE PKWY. | MIRAMAR | FL | 33025 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
