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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name N-Acetylprocainamide Control Materials
510(k) Number K851474
Device Name VYGON SPINAL ANESTHESIA TRAY CODE NO. 190
Applicant
Vygon Corp.
1 Madison St.
East Rutherford,  NJ  07073
Applicant Contact TONY J RIVERS
Correspondent
Vygon Corp.
1 Madison St.
East Rutherford,  NJ  07073
Correspondent Contact TONY J RIVERS
Regulation Number862.3280
Classification Product Code
LAZ  
Date Received04/15/1985
Decision Date 05/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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