FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
BEAVER R-K KNIFE
K Number: K852828
·
Decision Nov 4, 1985
Classifications
1
FEI Numbers
206
Registration Numbers
207
Same Product Code
53
Applicant Total
6
Review Days
125
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Basic Information
- Device Name
- BEAVER R-K KNIFE
- K Number
- K852828
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Rudolph Beaver, Inc.
- Date Received
- July 2, 1985
- Decision Date
- November 4, 1985
- Product Code
- HNN
- 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 |
|---|---|---|---|
| HNN | Knife, Ophthalmic | FDA class 1 | Ophthalmic |
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Other Clearances by Rudolph Beaver, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883361 | ARTHRO-TRAC(TM) | Oct 13, 1988 | Substantially Equivalent |
| K875030 | OCU-1 | May 3, 1988 | Substantially Equivalent |
| K862709 | MECHANICAL CYSTITOME | Aug 1, 1986 | Substantially Equivalent |
| K860305 | BEAVER MICRO-GEM GAUGE BLOCK | Feb 12, 1986 | Substantially Equivalent |
| K853129 | BEAVER MULTIPURPOSE SAPPHIRE KNIFE | Aug 6, 1985 | Substantially Equivalent |