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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze / Sponge,Nonresorbable For External Use
510(k) Number K940755
Device Name ISOLYER (4X4, 8PLY)
Applicant
Isolyer Co.
4320 International Blvd., NW
Norcross,  GA  30093
Applicant Contact TRAVIS HONEYCUTT
Correspondent
Isolyer Co.
4320 International Blvd., NW
Norcross,  GA  30093
Correspondent Contact TRAVIS HONEYCUTT
Regulation Number878.4014
Classification Product Code
NAB  
Date Received02/18/1994
Decision Date 05/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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