FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VENTROFIL TENSION RELIEF SUTURE SET
K Number: K904435
·
Decision Aug 29, 1991
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
19
Applicant Total
207
Review Days
335
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Basic Information
- Device Name
- VENTROFIL TENSION RELIEF SUTURE SET
- K Number
- K904435
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4930
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Aesculap, Inc.
- Date Received
- September 28, 1990
- Decision Date
- August 29, 1991
- Product Code
- KGS
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KGS | Retention Device, Suture | FDA class 1 | General, Plastic Surgery |
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