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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name carboxymethylcellulose sodium or polyvinyl methylether maleic acid calcium-sodium
510(k) Number K884357
Device Name PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM
Applicant
PRECISION DYNAMICS CORP.
POST OFFICE BOX 9043
VAN NUYS,  CA  91409
Applicant Contact GINO FRANCO
Correspondent
PRECISION DYNAMICS CORP.
POST OFFICE BOX 9043
VAN NUYS,  CA  91409
Correspondent Contact GINO FRANCO
Regulation Number872.3490
Classification Product Code
KOT  
Date Received10/17/1988
Decision Date 11/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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