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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K881913
Device Name PROTECTO-SHIELD
Applicant
Syntech Mfg. Services
1501 E Chapman Suite 352
Fullerton,  CA  92631
Applicant Contact NICK HERBERT
Correspondent
Syntech Mfg. Services
1501 E Chapman Suite 352
Fullerton,  CA  92631
Correspondent Contact NICK HERBERT
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/09/1988
Decision Date 07/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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