FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRODIMED MICROINJECTION PIPETTES
K Number: K983713
·
Decision Jun 8, 1999
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
25
Applicant Total
1
Review Days
230
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Basic Information
- Device Name
- PRODIMED MICROINJECTION PIPETTES
- K Number
- K983713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6130
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Prodimed
- Date Received
- October 21, 1998
- Decision Date
- June 8, 1999
- 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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