SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO— 510(k) K991700

Name: FDA 510(k) clearance K991700
Creator: U.S. Food and Drug Administration
Published: 1999-07-19

Substantially Equivalent

Swemed Lab International AB

FDA 510(k) clearance K991700 for SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO, Substantially Equivalent on 1999-07-19. Applicant: Swemed Lab International AB. Device class: 2.

Clearance details

Applicant: Swemed Lab International AB
Product code: Code MQH
Device class: Class 2
Regulation: 21 CFR 884.6130
Advisory panel: Obstetrics/Gynecology
Date received: 1999-05-18
Decision date: 1999-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billdal, SE

Download summary PDF View on FDA.gov ↗

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