FDA 510(k) Application Details - K962688
| Device Classification Name |
Dilator, Esophageal, Ent
More FDA Info for this Device |
| 510(K) Number |
K962688 |
| Device Name |
Dilator, Esophageal, Ent |
| Applicant |
BOSTON MEDICAL PRODUCTS, INC.
117 FLANDERS RD.
WESTBOROUGH, MA 01581 US
Other 510(k) Applications for this Company
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| Contact |
STUART K MONTGOMERY
Other 510(k) Applications for this Contact |
| Regulation Number |
874.4420
More FDA Info for this Regulation Number |
| Classification Product Code |
KCF
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
| Date Received |
07/11/1996 |
| Decision Date |
07/25/1996 |
| Decision |
SESE - SUBST EQUIV |
| Classification Advisory Committee |
EN - Ear, Nose, & Throat |
| Review Advisory Committee |
EN - Ear, Nose, & Throat |
| Statement / Summary / Purged Status |
Summary |
| Type |
Traditional |
| Reviewed By Third Party |
N |
| Expedited Review |
|
FDA Source Information for K962688
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