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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K850012
Device Name ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO
Applicant
HEYLTEX CORP.
10665 RICHMOND AVE.
SUITE 192
HOUSTON,  TX  77042
Applicant Contact PARR
Correspondent
HEYLTEX CORP.
10665 RICHMOND AVE.
SUITE 192
HOUSTON,  TX  77042
Correspondent Contact PARR
Regulation Number872.3930
Classification Product Code
LYC  
Date Received01/02/1985
Decision Date 04/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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