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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patient Examination Glove
510(k) Number K883805
Device Name ROCKET SEX CRIME KIT
Applicant
A & A Medical, Inc.
31a Business Park Dr.
Branford,  CT  06405
Applicant Contact CEDRIC K BERNBERG
Correspondent
A & A Medical, Inc.
31a Business Park Dr.
Branford,  CT  06405
Correspondent Contact CEDRIC K BERNBERG
Regulation Number880.6250
Classification Product Code
FMC  
Date Received09/07/1988
Decision Date 01/31/1989
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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