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FDA 510(k), K962431, CTM DISPOSABLE PAK
FDA 510(k), K962431, CTM DISPOSABLE PAK
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510(K) Number: K962431
Device Name: CTM DISPOSABLE PAK
Manufacturer: GLENN A DUNKI-JACOBS
Device Classification Name: Unit, Phacofragmentation
Regulation Number: HQC
Classification Product Code: KXA
Date Received: 06/24/1996
Decision Date: 07/23/1996
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: CTM DISPOSABLE PAK
Manufacturer: GLENN A DUNKI-JACOBS
Device Classification Name: Unit, Phacofragmentation
Regulation Number: HQC
Classification Product Code: KXA
Date Received: 06/24/1996
Decision Date: 07/23/1996
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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