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510(k) K041028

CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL by Crown Delta Corp. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2004
Date Received
April 21, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

Other clearances by Crown Delta Corp.

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  • 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)
  • K901991 — SILICONE ELASTOMER PUTTY (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)

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