FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS
K Number: K864003
·
Decision Oct 31, 1986
Classifications
1
FEI Numbers
275
Registration Numbers
276
Same Product Code
43
Applicant Total
33
Review Days
17
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Basic Information
- Device Name
- PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS
- K Number
- K864003
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Allergan, Inc.
- Date Received
- October 14, 1986
- Decision Date
- October 31, 1986
- Product Code
- HNR
- 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 |
|---|---|---|---|
| HNR | Forceps, Ophthalmic | FDA class 1 | Ophthalmic |
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