FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)
K Number: K972749
·
Decision Mar 13, 1998
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
10
Applicant Total
1
Review Days
233
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Basic Information
- Device Name
- PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)
- K Number
- K972749
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4100
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- C.M. Chance , Ltd.
- Date Received
- July 23, 1997
- Decision Date
- March 13, 1998
- Product Code
- HQR
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | FDA class 2 | Ophthalmic |
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