510(k) K770959

BOUGIE, FILIFORM, JACKSON by V. Mueller O.V. Baxter Healthcare Corp. — Product Code KBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1977
Date Received
May 27, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bougie, Eustachian
Device Class
Class I
Regulation Number
874.4175
Review Panel
EN
Submission Type