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510(k) K991273

SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE by Swemed Lab International AB — Product Code MQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1999
Date Received
April 13, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6100
Review Panel
OB
Submission Type

Other clearances by Swemed Lab International AB

  • K053208 — CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISIO (January 30, 2006)
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  • K991700 — SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING (July 19, 1999)

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