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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Assisted Reproduction
510(k) Number K991216
Device Name HOFFMAN IVF-1
Applicant
(Arms) Hoffman Surgical Equipment, Ivf Division
555 N. Ln.
Suite 5001
Conshohocken,  PA  19428
Applicant Contact FRANK STRZEMPEK
Correspondent
(Arms) Hoffman Surgical Equipment, Ivf Division
555 N. Ln.
Suite 5001
Conshohocken,  PA  19428
Correspondent Contact FRANK STRZEMPEK
Regulation Number884.6120
Classification Product Code
MQG  
Date Received04/09/1999
Decision Date 08/05/1999
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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