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FDA 510(k), K952638, 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[
FDA 510(k), K952638, 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[
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510(K) Number: K952638
Device Name: 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[
Manufacturer: BAXTER EDWARDS
Device Classification Name: Angioscope
Regulation Number: 876.1500
Classification Product Code: LYK
Date Received: 06/09/1995
Decision Date: 07/28/1995
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[
Manufacturer: BAXTER EDWARDS
Device Classification Name: Angioscope
Regulation Number: 876.1500
Classification Product Code: LYK
Date Received: 06/09/1995
Decision Date: 07/28/1995
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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