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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mammary Sizer
510(k) Number K961356
Device Name MAMMARY SIZER
Applicant
General Surgical Innovations
3172a Porter Dr.
Palo Alto,  CA  94304
Applicant Contact THERESA M NARAROFF
Correspondent
General Surgical Innovations
3172a Porter Dr.
Palo Alto,  CA  94304
Correspondent Contact THERESA M NARAROFF
Classification Product Code
MRD  
Date Received04/08/1996
Decision Date 09/23/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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