FDA 510(k) Applications for Medical Device:
Dilator, Esophageal
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K983373 | B. BRAUN/MCGAW |
824 12TH AVE. | BETHLEHEM | PA | 18018-0027 |
| K961438 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K971320 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K122924 | BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K974788 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K061787 | BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K033936 | C.R. BARD, INC. |
129 CONCORD ROAD | BILLERICA | MA | 01821 |
| K061937 | COOK ENDOSCOPY |
4900 BETHANIA STATION RD. | WINSTON-SALEM | NC | 27105 |
| K090183 | COOK ENDOSCOPY |
4900 BETHANIA STATION RD. | WINSTON-SALEM | NC | 27105 |
| K993720 | CORDIS CORP. |
14201 N.W. 60TH AVE. | MIAMI LAKES | FL | 33014 |
| K023907 | CORDIS CORP. |
7 POWDER HORN DR. | WARREN | NJ | 07059 |
| K043605 | CORDIS EUROPA, N.V. |
OOSTEINDE 8 | RODEN | NL-9301 LJ | |
| K060302 | CORDIS EUROPA, N.V. |
OOSTEINDE 8 | RODEN, DRENTHE | NL-9301 LJ | |
| K093236 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K031147 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K002363 | MEDOVATIONS, INC. |
1294 BARCLAY BLVD. | BUFFALO GROVE | IL | 60089 |
| K990935 | PILLING WECK SURGICAL |
420 DELAWARE DR. | FORT WASHINGTON | PA | 19034 |
| K082995 | SAFESTITCH MEDICAL |
4400 BISCAYNE BLVD. | MIAMI | FL | 33137 |
| K971615 | TRI-MED SPECIALTIES, INC. |
16309 WEST 108TH CIRCLE | LENEXA | KS | 66219 |
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