FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET
K Number: K953289
·
Decision Aug 21, 1995
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
89
Applicant Total
45
Review Days
38
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Basic Information
- Device Name
- TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET
- K Number
- K953289
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Davis & Geck, Inc.
- Date Received
- July 14, 1995
- Decision Date
- August 21, 1995
- Product Code
- DXZ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | FDA class 2 | Cardiovascular |
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