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510(k) K862364

NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS) by Swemed Laboratories, Inc. — Product Code HEM

Clearance Details

Decision
SN ()
Decision Date
August 19, 1986
Date Received
June 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Imager, Ultrasonic Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.2225
Review Panel
OB
Submission Type

Other clearances by Swemed Laboratories, Inc.

  • K862365 — NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE (July 7, 1986)

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