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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Percussor
510(k) Number K891571
Device Name PERCUSSION HAMMER
Applicant
Sandal Surgico
Industrial Estate P.O. Box
# 224
Sialkot,  PK
Applicant Contact A. Q SANDAL
Correspondent
Sandal Surgico
Industrial Estate P.O. Box
# 224
Sialkot,  PK
Correspondent Contact A. Q SANDAL
Regulation Number882.1700
Classification Product Code
GWZ  
Date Received03/20/1989
Decision Date 03/31/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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