Atlas FDA

H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET

FDA 510(k) clearance K913287 · decided 1991-12-18

Clearance details

K-number
K913287
Device name
H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET
Applicant
River Medical, Inc.
Decision
Substantially Equivalent
Date received
1991-07-24
Decision date
1991-12-18
Days to decision
147 days
Clearance type
Traditional
Product code
ETB
Device class
2
Regulation number
874.3450
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Memphis, TN, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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Recalls involving this device

No recalls on record reference this clearance.