FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DORC CORNEAL PUNCH BLOCK
K Number: K830335
·
Decision Mar 9, 1983
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
2
Applicant Total
92
Review Days
36
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Basic Information
- Device Name
- DORC CORNEAL PUNCH BLOCK
- K Number
- K830335
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Jedmed Instrument Co.
- Date Received
- February 1, 1983
- Decision Date
- March 9, 1983
- Product Code
- HNJ
- 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 |
|---|---|---|---|
| HNJ | Punch, Corneo-Scleral | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNJ), ordered by most recent decision date.
TANNE CORNEAL CUTTING BLOCK
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REPL. PISTON FOR TROUTMAN CORNEAL PUNCH
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| K953457 | JEDMED SPECTRUM ENT CABINET | Aug 11, 1995 | Substantially Equivalent |
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| K950078 | MICROFLOW IRRIGATION SYSTEM | Jun 21, 1995 | Substantially Equivalent |
| K944671 | VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) | Feb 7, 1995 | Substantially Equivalent |
| K944031 | VIDEO SCOPE SYSTEM (OTOSCOPE) | Sep 23, 1994 | Substantially Equivalent |