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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name marker, skin
510(k) Number K861772
Device Name LASER SKIN MARKER AND MASK WHITE LOTION
Applicant
PACIFIC POLY CRAFTS
205 NORTH GARDEN ST.
VENTURA,  CA  93001 -2532
Applicant Contact JANET R SEREGELY
Correspondent
PACIFIC POLY CRAFTS
205 NORTH GARDEN ST.
VENTURA,  CA  93001 -2532
Correspondent Contact JANET R SEREGELY
Regulation Number878.4660
Classification Product Code
FZZ  
Date Received05/07/1986
Decision Date 05/21/1986
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
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