Part B: SUPPLEMENTARY INFORMATION
ANSI , . () |
| Address of Standards Organization: |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED) |
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| Devices Affected: |
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| Processes Affected: |
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| Type of Standard: |
| National, Vertical |
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §886.3600 |
Lens, Multifocal Intraocular |
Class 3 |
MFK |
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| FDA Technical Contact: |
| Don Calogero |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2500 |
| Silver Spring MD 20993 |
| 301/796-6483 |
| Email: don.calogero@fda.hhs.gov |
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