FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE STRIPPER PGD
K Number: K041435
·
Decision Sep 29, 2004
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
25
Applicant Total
4
Review Days
124
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Basic Information
- Device Name
- THE STRIPPER PGD
- K Number
- K041435
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6130
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mid-Atlantic Diagnostics, Inc.
- Date Received
- May 28, 2004
- Decision Date
- September 29, 2004
- 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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