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510(k) Submission – CT SPACER (K010680, Clinical Technologies, Inc.)
510(k) Submission – CT SPACER (K010680, Clinical Technologies, Inc.)
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510(K) Number: K010680
Device Name: CT SPACER
Manufacturer: CLINICAL TECHNOLOGIES, INC.
Device Classification Name: Nebulizer (Direct Patient Interface)
Regulation Number: 868.5630
Classification Product Code: CAF
Date Received: 03/07/2001
Decision Date: 05/23/2001
Regulation Medical Specialty: Anesthesiology
Request Contents: 510(k) submission for K010680 – Device Name: CT SPACER by CLINICAL TECHNOLOGIES, INC., 705 E. Virginia Way Suite 1, Barstow, CA 92311
Device Name: CT SPACER
Manufacturer: CLINICAL TECHNOLOGIES, INC.
Device Classification Name: Nebulizer (Direct Patient Interface)
Regulation Number: 868.5630
Classification Product Code: CAF
Date Received: 03/07/2001
Decision Date: 05/23/2001
Regulation Medical Specialty: Anesthesiology
Request Contents: 510(k) submission for K010680 – Device Name: CT SPACER by CLINICAL TECHNOLOGIES, INC., 705 E. Virginia Way Suite 1, Barstow, CA 92311
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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