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FDA 510(k), K101223, SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
FDA 510(k), K101223, SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
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510(K) Number: K101223
Device Name: SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
Manufacturer: HEIDELBERG ENGINEERING
Device Classification Name: tomography, optical coherence
Regulation Number: 886.1570
Classification Product Code: OBO
Date Received: 05/03/2010
Decision Date: 10/01/2010
Regulation Medical Specialty: Ophthalmic
Device Name: SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
Manufacturer: HEIDELBERG ENGINEERING
Device Classification Name: tomography, optical coherence
Regulation Number: 886.1570
Classification Product Code: OBO
Date Received: 05/03/2010
Decision Date: 10/01/2010
Regulation Medical Specialty: Ophthalmic
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- Delivery: Approximately 1 to 2 weeks
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