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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K911815
Device Name 3RD HAND HELPER
Applicant
Aaron Medical Industries
1640 Central Ave.
St. Petersburg,  FL  33712
Applicant Contact ROBERT SARON
Correspondent
Aaron Medical Industries
1640 Central Ave.
St. Petersburg,  FL  33712
Correspondent Contact ROBERT SARON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/24/1991
Decision Date 08/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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