FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERIGUARD PERICARDIAL PATCH
K Number: K821532
·
Decision Aug 19, 1982
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
89
Applicant Total
3
Review Days
87
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Basic Information
- Device Name
- PERIGUARD PERICARDIAL PATCH
- K Number
- K821532
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Genetic Laboratories, Inc.
- Date Received
- May 24, 1982
- Decision Date
- August 19, 1982
- 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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