Home / 510(k) Clearances / K003056

510(k) K003056

OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218 by Labotect Labor-Technik Gottingen — Product Code MQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2000
Date Received
October 1, 2000
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 Labotect Labor-Technik Gottingen

  • K021438 — INSEMINATION CATHETER, MODEL 320301 (July 16, 2002)
  • K000950 — EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201 (May 12, 2000)

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