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510(k) K861490

PERMACLEAR SOLUTION CAT. NO. 4950 by Helena Laboratories — Product Code KEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1986
Date Received
April 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Clearing
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

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  • K842721 — LIMONENE (August 3, 1984)
  • K832011 — AMERI CLEAR (August 12, 1983)
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