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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 K920682
Device Name PHOENIX STERI-TECH STERILE DENTAL PACK GEN-10001
Applicant
Phoenix Steri-Tech, Inc.
P.O. Box 488
Suwanee,  GA  30174
Applicant Contact SHEPHERD, JR.
Correspondent
Phoenix Steri-Tech, Inc.
P.O. Box 488
Suwanee,  GA  30174
Correspondent Contact SHEPHERD, JR.
Regulation Number878.4040
Classification Product Code
FXX  
Date Received02/14/1992
Decision Date 04/28/1992
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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