Atlas FDA

BOUGIE, FILIFORM, JACKSON

FDA 510(k) clearance K770959 · decided 1977-06-14

Clearance details

K-number
K770959
Device name
BOUGIE, FILIFORM, JACKSON
Applicant
V. Mueller O.V. Baxter Healthcare Corp.
Decision
Substantially Equivalent
Date received
1977-05-27
Decision date
1977-06-14
Days to decision
18 days
Clearance type
Traditional
Product code
KBI
Device class
1
Regulation number
874.4175
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.