Atlas FDA

CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)

FDA 510(k) clearance K963899 · decided 1997-08-22

Clearance details

K-number
K963899
Device name
CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
Applicant
Exmoor Plastics , Ltd.
Decision
Substantially Equivalent
Date received
1996-09-27
Decision date
1997-08-22
Days to decision
329 days
Clearance type
Traditional
Product code
ETA
Device class
2
Regulation number
874.3495
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Taunton, GB
Third-party review
No
Expedited review
No

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RecordFirmDate
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Recalls involving this device

No recalls on record reference this clearance.