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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 N. Garden St.
Ventura,  CA  93001
Applicant Contact JANET R SEREGELY
Correspondent
Pacific Poly Crafts
205 N. Garden St.
Ventura,  CA  93001
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
Predetermined Change
Control Plan Authorized		 No
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