FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYSTEM 1 INSTRUMENT STAND
K Number: K803195
·
Decision Feb 4, 1981
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
14
Applicant Total
4
Review Days
50
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Basic Information
- Device Name
- SYSTEM 1 INSTRUMENT STAND
- K Number
- K803195
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1860
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Surgical Mechanical Research, Inc.
- Date Received
- December 16, 1980
- Decision Date
- February 4, 1981
- Product Code
- HMF
- 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 |
|---|---|---|---|
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | FDA class 1 | Ophthalmic |
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