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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameAPPLIED LABORATORIES STERILE SALINE SOLUTION
Classification Nameaccessories, soft lens products
Generic Namesaline solution in pressurized container
Regulation Number886.5928
ApplicantAPPLIED LABORATORIES, INC.
PMA NumberP870002
Supplement NumberS011
Date Received04/15/1992
Decision Date09/01/1992
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
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