FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EFFNER CAUTERY INSTRUMENTS
K Number: K875260
·
Decision Jun 6, 1988
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
23
Applicant Total
4
Review Days
167
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Basic Information
- Device Name
- EFFNER CAUTERY INSTRUMENTS
- K Number
- K875260
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4115
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Effner and Spreine Co.
- Date Received
- December 22, 1987
- Decision Date
- June 6, 1988
- Product Code
- HQP
- 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 |
|---|---|---|---|
| HQP | Unit, Cautery, Thermal, Battery-Powered | FDA class 2 | Ophthalmic |
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