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510(k) K911166

DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 by Diagnostic Ultrasound Corp. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1991
Date Received
March 15, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

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  • K915436 — BLADDERSCAN BVI 2500 (March 3, 1992)
  • K911125 — DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 (August 15, 1991)

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