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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Instrument, Microsurgical
510(k) Number K873934
Device Name RANGE OF CROCODILE ACTION INSTRUMENTS
Applicant
DOWNS SURGICAL LTD.
PARKWAY CLOSE,PARKWAY
INDUSTRIAL ESTATE
SHEFFIELD S9 4WJ,  GB
Applicant Contact GEOFFREY W DOWN
Correspondent
DOWNS SURGICAL LTD.
PARKWAY CLOSE,PARKWAY
INDUSTRIAL ESTATE
SHEFFIELD S9 4WJ,  GB
Correspondent Contact GEOFFREY W DOWN
Regulation Number882.4525
Classification Product Code
GZX  
Date Received09/25/1987
Decision Date 12/17/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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