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510(k) K941197

SILK*SKIN SCAR TREATMENT by Puritas Health Care, Inc. — Product Code MDA

K941197 is an FDA 510(k) premarket notification submitted by Puritas Health Care, Inc. for the device "SILK*SKIN SCAR TREATMENT". The FDA issued a decision of Substantially Equivalent on August 11, 1994. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Puritas Health Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1994
Date Received
March 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elastomer, Silicone, For Scar Management
Device Class
Class I
Regulation Number
878.4025
Review Panel
SU
Submission Type

Other clearances by Puritas Health Care, Inc.

  • K942339 — SKIN NEUVEAU SCAR TREATMENT (November 28, 1994)
  • K935600 — TRACHEAL SUCTION CATHETER (May 10, 1994)
  • K935531 — OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP (May 5, 1994)
  • K940074 — Y-TYPE BLOOD ADMINISTRATION SET (April 21, 1994)
  • K940054 — MEASURED VOLUME SOLUTION ADMINISTRATION SET (April 15, 1994)
  • K940055 — MULTISET (April 15, 1994)
  • K935583 — SUCTION SET, TRACHAEL (April 11, 1994)
  • K940056 — WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM (April 4, 1994)
  • K940070 — STOPCOCK INTRAVENOUS THERAPY (April 4, 1994)
  • K935532 — TRANSFER SET (April 4, 1994)

Other clearances for product code MDA

  • K112131 — NEODYNE DRESSING (September 29, 2011)
  • K111733 — CORELEADER SCAR-DIMMER (September 22, 2011)
  • K083718 — BEAU RX SCAR CARE GEL (January 26, 2009)
  • K053481 — KELO-COTE SPRAY (April 14, 2006)
  • K041704 — NEWGEL AND NEWGEL PLUS E (October 17, 2005)
  • K040307 — HANSON SCAR ADE (August 12, 2004)
  • K024057 — CURAD SCAR THERAPY (June 18, 2003)
  • K024160 — NEOSPORIN SCAR SOLUTION (March 17, 2003)
  • K023678 — DIMISIL SCAR GEL (January 23, 2003)
  • K023136 — OLEEVA FABRIC (October 16, 2002)

FDA data resources