Part B: SUPPLEMENTARY INFORMATION
USP , . () |
| Address of Standards Organization: |
| United States Pharmacopeial Convention, Inc. (USP) |
| 12601 Twinbrook Parkway |
| Rockville, MD 20852 |
| |
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| CDRH Office and Division Associated with Recognized Standards: |
| ALL OFFICES AND DIVISIONS IN CDRH |
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| Devices Affected: |
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| Processes Affected: |
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| Type of Standard: |
| Vertical, National |
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.2800 |
Indicator, Biological Sterilization Process |
Class 2 |
FRC |
| |
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| FDA Technical Contact: |
| Anne D. Lucas |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 64, Room 4010 |
| Silver Spring MD 20993 |
| 301/796-0283 |
| Email: anne.lucas@fda.hhs.gov |
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