Home / 510(k) Clearances / K991700

510(k) K991700

SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO by Swemed Lab International AB — Product Code MQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1999
Date Received
May 18, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microtools, Assisted Reproduction (Pipettes)
Device Class
Class II
Regulation Number
884.6130
Review Panel
OB
Submission Type

Other clearances by Swemed Lab International AB

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  • K022643 — BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 (November 5, 2002)
  • K991273 — SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE (August 18, 1999)

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  • K102480 — INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZO (April 19, 2011)
  • K092554 — BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES (April 30, 2010)
  • K072600 — INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL (May 19, 2008)