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510(k) K022643

BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 by Swemed Lab International AB — Product Code MQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2002
Date Received
August 8, 2002
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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  • K991700 — SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING (July 19, 1999)

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