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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Expander, Breast, External
510(k) Number K770082
Device Name SALONMAY BUSTLINE INCREASER
Applicant
Gamma Enterprises, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Gamma Enterprises, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5660
Classification Product Code
MWZ  
Date Received01/14/1977
Decision Date 03/16/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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