FDA 510(k) Application Details - K944949

Device Classification Name Strap, Head, Gas Mask

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510(K) Number K944949
Device Name Strap, Head, Gas Mask
Applicant VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA, NJ US
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Contact JING ZHANG
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Regulation Number 868.5560

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Classification Product Code BTK
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Date Received 10/07/1994
Decision Date 11/14/1994
Decision SK - Substantially Equivalent - Kit
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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