FDA 510(k) Application Details - K972338

Device Classification Name Restraint, Protective

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510(K) Number K972338
Device Name Restraint, Protective
Applicant GERIATRIC PRODUCTS, INC.
P.O. BOX 4341
CROFTON, MD 21114 US
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Contact E.J. Smith
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Regulation Number 880.6760

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Classification Product Code FMQ
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Date Received 06/23/1997
Decision Date 07/24/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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