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FDA 510(k), K133665, MALLEABLE SUCTION INSTRUMENTS
FDA 510(k), K133665, MALLEABLE SUCTION INSTRUMENTS
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510(K) Number: K133665
Device Name: MALLEABLE SUCTION INSTRUMENTS
Manufacturer: CHARLES M COPPERBERG
Device Classification Name: Ear, Nose, And Throat Stereotaxic Instrument
Regulation Number: PGW
Classification Product Code: KXA
Date Received: 11/29/2013
Decision Date: 03/13/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
Device Name: MALLEABLE SUCTION INSTRUMENTS
Manufacturer: CHARLES M COPPERBERG
Device Classification Name: Ear, Nose, And Throat Stereotaxic Instrument
Regulation Number: PGW
Classification Product Code: KXA
Date Received: 11/29/2013
Decision Date: 03/13/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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