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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Specialized Obstetric-Gynecologic
510(k) Number K990045
Device Name BERACLAMP, MODEL BC-1
Applicant
Poamax LLC
17 Alphus St.
Poguoson,  VA  23662
Applicant Contact MICHAEL J PALMER
Correspondent
Poamax LLC
17 Alphus St.
Poguoson,  VA  23662
Correspondent Contact MICHAEL J PALMER
Regulation Number884.4530
Classification Product Code
KNA  
Date Received01/06/1999
Decision Date 05/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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