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510(k) K901991

SILICONE ELASTOMER PUTTY by Crown Delta Corp. — Product Code MDA

K901991 is an FDA 510(k) premarket notification submitted by Crown Delta Corp. for the device "SILICONE ELASTOMER PUTTY". The FDA issued a decision of Substantially Equivalent on September 14, 1990. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Crown Delta Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1990
Date Received
May 2, 1990
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 Crown Delta Corp.

  • K122974 — TRYOUT-VPS HOLDING PASTE (May 17, 2013)
  • K041028 — CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL (May 14, 2004)
  • K955288 — HEARING AID IMPRESSION MATERIAL (February 2, 1996)
  • K940132 — PODIATRIC MATERIAL (September 29, 1994)
  • K930248 — VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM (January 7, 1994)
  • K926150 — VINYL ADDITION SILICONE SYSTEM (July 14, 1993)
  • K901990 — VINYL SILICONE ELASTOMER MATERIAL (September 14, 1990)
  • K872745 — VINYL POLYSILOXANE IMPRESSION SYSTEM (July 21, 1987)
  • K871409 — VINYL POLYSILOXANE IMPRESSION SYSTEM (June 11, 1987)
  • K843145 — TWO COMPONENT RTV VINYL SILICONE MATER (October 18, 1984)

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