FDA 510(k) Application Details - K771843

Device Classification Name

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510(K) Number K771843
Device Name WETTING AGENTS
Applicant GAMMA ENTERPRISES, INC.

, US
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Regulation Number

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Classification Product Code
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Date Received 09/21/1977
Decision Date 11/22/1977
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee -
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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