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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K921822
Device Name FRAY BIO-PUNCH
Applicant
Fray Products Corp.
107 Lorelee Dr.
Tonawanda,  NY  14150
Applicant Contact FRED W LIESINGER
Correspondent
Fray Products Corp.
107 Lorelee Dr.
Tonawanda,  NY  14150
Correspondent Contact FRED W LIESINGER
Regulation Number878.4800
Classification Product Code
MDM  
Date Received04/16/1992
Decision Date 10/28/1992
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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