SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO
FDA 510(k) clearance K991700 · decided 1999-07-19
Clearance details
- K-number
- K991700
- Device name
- SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO
- Applicant
- Swemed Lab International AB
- Decision
- Substantially Equivalent
- Date received
- 1999-05-18
- Decision date
- 1999-07-19
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- MQH
- Device class
- 2
- Regulation number
- 884.6130
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Billdal, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.