Recognition List Number: 018 Publication Date: 09/12/2007
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 10-50: ISO 11979-10 First edition 2006-08-15, Ophthalmic implants -- Intraocular lenses -- Part 10: Phakic intraocular lenses. (Ophthalmic)
Date of Standard: 2006. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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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: |
| Phakic Intraocular lenses (IOL) |
|
| Processes Affected: |
| PMA, IDE, PDP, HDE, Design Contol Input |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
| Complete standard and any annexes. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Lens, Intraocular, Phakic |
Class 3 |
MTA |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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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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