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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameISPAN SULFUR HEXAFLUORIDE SF6 GAS
Classification Namegases used within eye to place pressure on detached retina
Regulation Number886.4270
ApplicantAIR LIQUIDE HEALTHCARE
PMA NumberP900067
Supplement NumberS007
Date Received12/22/2011
Decision Date01/20/2012
Product Code
LPO[ Registered Establishments with LPO ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Replace the ion chromatograph for quality control product testing.
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