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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K923662
Device Name INGROWN TOENAIL PAD
Applicant
Many Bee Co.
43 W. Rose Ln.
Phoenix,  AZ  85013
Applicant Contact JAMES J BERENS
Correspondent
Many Bee Co.
43 W. Rose Ln.
Phoenix,  AZ  85013
Correspondent Contact JAMES J BERENS
Regulation Number880.5240
Classification Product Code
KGX  
Date Received07/22/1992
Decision Date 04/20/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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