FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA
K Number: K102480
·
Decision Apr 19, 2011
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
25
Applicant Total
1
Review Days
232
Basic Information
- Device Name
- INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA
- K Number
- K102480
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6130
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- JIEYING LABORATORY INC.
- Date Received
- August 30, 2010
- Decision Date
- April 19, 2011
- Product Code
- MQH
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQH | Microtools, Assisted Reproduction (Pipettes) | FDA class 2 | Obstetrics/Gynecology |
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