510(k) K902124
- Device
- Dowd Catheter
- Applicant
- BOSTON SCIENTIFIC CORP.
- 510(k) number
- K902124
- Product code
- FAH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-08-09
- Date received
- 1990-05-11
- Regulation
- 876.5520
- Classification name
- Dilator, Urethral, Mechanical
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEO L BASTA
- Address
- 480 Pleasant St. P.O. Box 7407 Watertown MA US 02272 02272
FDA Registration Numbers#
- 3010707607
- 3012322232
- 3013497507
- 8044098
- 3010202439
- 9610617
- 3006546082
- 2020550
- 3014342096
Source Documents#
510(k) summary PDF not indicated by FDA