FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CBS STRAW
K Number: K002595
·
Decision Nov 17, 2000
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
45
Applicant Total
2
Review Days
88
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Basic Information
- Device Name
- CBS STRAW
- K Number
- K002595
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6120
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cryo Bio System
- Date Received
- August 21, 2000
- Decision Date
- November 17, 2000
- Product Code
- MQG
- 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 |
|---|---|---|---|
| MQG | Accessory, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Cryo Bio System
| K Number | Device Name | ||
|---|---|---|---|
| K092398 | HSV STRAW | Oct 6, 2010 | Substantially Equivalent |