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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K994158
Device Name MACROSORBOS PROTECTIVE SHEET
Applicant
MACROPORE BIOSURGERY, INC.
4329 GRAYDON RD.
san diego,  CA  92130
Applicant Contact floyd g larson
Correspondent
MACROPORE BIOSURGERY, INC.
4329 GRAYDON RD.
san diego,  CA  92130
Correspondent Contact floyd g larson
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   MAI  
Date Received12/09/1999
Decision Date 07/24/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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