FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MCDONALD FOLDING FORCEPS
K Number: K885230
·
Decision May 17, 1989
Classifications
1
FEI Numbers
275
Registration Numbers
276
Same Product Code
43
Applicant Total
47
Review Days
148
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Basic Information
- Device Name
- MCDONALD FOLDING FORCEPS
- K Number
- K885230
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Alcon Laboratories
- Date Received
- December 20, 1988
- Decision Date
- May 17, 1989
- 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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| K983973 | OPTI-ONE MULTI-PURPOSE SOLUTION | Dec 18, 1998 | Substantially Equivalent |
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| K981571 | MONARCH IOL DELIVERY SYSTEM | Jul 9, 1998 | Substantially Equivalent |