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510(k) K912730

ROCKET SURGICAL SKIN MARKING PEN by West Texas Lighthouse For the Blind — Product Code FZZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1991
Date Received
June 20, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Skin
Device Class
Class I
Regulation Number
878.4660
Review Panel
SU
Submission Type

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  • K844865 — SECURLINE SURGICAL SKIN MARKER 1000 (January 14, 1985)