FDA 510(k) Applications for Medical Device:
Endoscopic Grasping/Cutting Instrument, Non-Powered
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K971202 | COMEG ENDOSKOPIE GMBH |
13790 E. RICE PLACE | AURORA | CO | 80015 |
| K101298 | ENDOCHOICE, INC. |
11800 WILLIS RD | ALPHARETTA | GA | 30009 |
| K973259 | MEDICAL CREATIVE TECHNOLOGIES, INC. |
2950-N ADVANCE LN. | COLMAR | PA | 18915-9727 |
| K973071 | MEDICAL ENGINEERING LABORATORY, INC. |
108 WEST WARREN ST., SUITE 207 | SHELBY | NC | 28150 |
| K152802 | MICRO-TECH (NANJING) CO., LTD. |
NO. 10 GAOKE THIRD ROAD | NANJING | 210032 | |
| K072684 | MONDEAL NORTH AMERICA, INC |
PO BOX 500521 | SAN DIEGO | CA | 92150 |
| K955063 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K961611 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K955066 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K955051 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K971123 | PHX TECHNOLOGIES CORP. |
1032 SHADY OAKS DR., NO. 100 | DENTON | TX | 76205 |
| K965176 | PILLING WECK GROUP |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K051276 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K141058 | SLATER ENDOSCOPY, LLC |
1135 W NASA BLVD. SUITE 500 | MELBOURNE | FL | 32901 |
| K150939 | SLATER ENDOSCOPY, LLC |
14000 NW 58TH COURT | MIAMI LAKES | FL | 33014 |
| K010412 | TELEMED SYSTEMS, INC. |
8 KANE INDUSTRIAL DR. | HUDSON | MA | 01749 |
| K974300 | TELEMED SYSTEMS, INC. |
19 BRIGHAM ST., UNIT 1 | MARLBOROUGH | MA | 01752 |
| K012074 | THE OLYMPUS OPTICAL CO. |
TWO CORPORATE DR. | MELVILLE | NY | 11747 |
| K970982 | TRI-MED SPECIALTIES, INC. |
16309 WEST 108TH CIRCLE | LENEXA | KS | 66219 |
| K120084 | UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. | MENTOR | OH | 44060 |
| K133736 | UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. | MENTOR | OH | 44060 |
| K103688 | USGI MEDICAL |
1140 CALLE CORDILLERA | SAN CLEMENTE | CA | 92673 |
| K191900 | Zhejiang Chuangxiang Medical Technology Co., LTD. |
301B, No.22, XinYan Road | Hanzhou | 311100 |
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