FDA 510(k) Application Details - K760849

Device Classification Name Specula, Ophthalmic

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510(K) Number K760849
Device Name Specula, Ophthalmic
Applicant V. MUELLER O.V. BAXTER HEALTHCARE CORP.

, US
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Regulation Number 886.4350

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Classification Product Code HNC
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Date Received 10/15/1976
Decision Date 11/02/1976
Decision SE - Substantially Equivalent
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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