FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SURGIFLATOR-30
K Number: K973432
·
Decision Dec 9, 1997
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
176
Applicant Total
26
Review Days
90
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Basic Information
- Device Name
- SURGIFLATOR-30
- K Number
- K973432
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- W.O.M. World of Medicine GmbH
- Date Received
- September 10, 1997
- Decision Date
- December 9, 1997
- Product Code
- HIF
- 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 |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | FDA class 2 | Obstetrics/Gynecology |
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