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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retainer, Surgical
510(k) Number K893870
Device Name ADAMS BREAST IMPLANT PROTECTOR
Applicant
ADEPT-MED INTL., INC.
3293 SARATOGA LN.
PO BOX 1777
CAMERON PARK,  CA  95682
Applicant Contact KATHLEEN QUIGLEY
Correspondent
ADEPT-MED INTL., INC.
3293 SARATOGA LN.
PO BOX 1777
CAMERON PARK,  CA  95682
Correspondent Contact KATHLEEN QUIGLEY
Regulation Number878.4800
Classification Product Code
GCZ  
Date Received05/26/1989
Decision Date 07/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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