FDA 510(k) Application Details - K961287

Device Classification Name Bottle, Collection, Vacuum

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510(K) Number K961287
Device Name Bottle, Collection, Vacuum
Applicant ROCKET MEDICAL PLC
FACTORIES 3 & 4,
WEAR INDUSTRIAL ESTATE
WASHINGTON, TYNE & WEAR NE37 1NE GB
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Contact L TODD
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Regulation Number 880.6740

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Classification Product Code KDQ
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Date Received 04/03/1996
Decision Date 07/26/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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